Quality Engineer

Found in: Talent CA C2 - 2 weeks ago

New Tecumseth, Canada Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

You role at Baxter

As part of the Quality Operations team, ensure Quality compliance for the assigned departments. 

Support a manufacturing 3-shift operation, with requirement to support plant shutdown where applicable.

Partner with Quality and Production personnel to ensure robustcomplaint and CAPA investigations are performed and mitigating actions are identified and implemented.

Lead robust product complaint investigations and DMAIC Nonconformance/CAPA investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements.

Utilize the Trackwise system for documentation of complaint evaluation tasks and CAPA investigation results.

Support initiation of new nonconformance events for in the Trackwise system, as required.

Provide front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.

Provide support for the Quality technical review/approval of department related procedural changes.

Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and ISO requirements. - Partner with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions.

Partner with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.

Support the Quality IT Systems for the department (i.e. SPC Infinity). 

What you will do:

Supports initiation of new nonconformance events for the Viaflex Mixing/Filling department in the Trackwise system. Leads robust DMAIC Nonconformance/CAPA and complaint investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements. Partners with Quality and Production personnel to ensure mitigating actions are identified and implemented. Utilizes the Trackwise system for documentation of nonconformance/CAPA investigation results. Partners with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions. Design IQ/OQ/PQ and validation campaigns as well as develop, prepare and write the protocols for process validation, cleaning validation, IQ/OQ and performance qualification Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance. - Monitor and support the execution of the protocols through training, facilitating and problem solving activities Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control. Write protocols, manage the execution of validationtesting plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages. - Perform retrospective validation packages as required for legacy systems and processes. Prepare or assist in the preparation of Validation Maintenance packages. Provides front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken. Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols. - Remains current with respect to regulatory trends and divisional issues. Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.  Partners with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs. - Support the Quality IT Systems for the department (i.e. SPC Infinity).  Completes requested month end summary/metric reports for Management Review meeting. Support the Baxter Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created.

What do you bring

Bachelor of Science, required. - ASQ Certified Quality Engineer, preferred. Major Subjects / Specialties - Science (Chemistry, Microbiology, Pharmacy, Engineering), required. Type of Experience Required: - Manufacturing & Quality background Previous experience in a GMP environment Knowledge of GMP, ISO and Regulatory standards Professional Engineer Certificate is a must Preferred: Knowledge of Corporate Quality requirements Years of Experience - 2 – 3 years experience in a pharmaceutical environment, required. 5+ years of successful experience in a pharmaceutical environment, preferred. Additional Skills / Special Training / Technical Skills Required: Certified Greenbelt designation. Strong understanding of Health Canada GMP and Medical Device Regulations. Thorough knowledge of applicable procedures, specifications, regulations and standards. Strong process and project managementcapabilities. - Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization. - Ability to build strong relationships with internal and external customers. - Strong ability to balance multiple priorities. n/Proficiency of Minitab

  • Quality Inspector

    1 day ago

    New Westminster, Canada Aecon Group Full time

    **Come Build Your Career at Aecon!** As a Canadian leader in infrastructure development, Aecon is safely and sustainably building what matters for future generations to thrive! We lead some of the most impactful infrastructure projects of our generation, at the forefront of transformational change in transportation and energy, and partnering every day to...

  • Quality Inspector

    7 days ago

    New Hamburg, Canada Ontario Drive & Gear Limited Full time

    **Essential Duties and Responsibilities**: - Interpret basic CAD models and drawings to develop new CMM programs for existing production and prelaunch parts. - Create and maintain operator work instructions for the use of various pieces of inspection equipment. - Assist Production with first piece and in-process inspection of production parts for...

  • Filling In-Process Checker/MH

    Found in: Talent CA C2 - 1 week ago

    New Tecumseth, Canada Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Students and co-op production positions at Honda of Canada Mfg.

    Found in: Talent CA 2 C2 - 1 week ago

    New Tecumseth, Canada CB Canada Full time

    Co-op & Student production positions at Honda of Canada Mfg. Alliston Ontario Pay $18.04 Start August or September 2022 to December 23, 2022 It takes a world-class team to build a world-class vehicle. At Honda of Canada Mfg. (HCM) the quality of our products and the unstoppable spirit of our highly skilled associates have allowed us to continually set new...

  • Production Technician, Mixing

    Found in: Talent CA C2 - 1 week ago

    New Tecumseth, Canada Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Project Manager Engineering

    Found in: beBee jobs CA - 1 week ago

    New Westminster, British Columbia, Canada TEEMA Full time

    Job Title: Project Manager – EngineeringJob ID: CV Location: New Westminster, BCOverview:The Project Manager – Engineering plans manages, executes, and controls enterprise-wide, cross-functional, high-risk, technology projects with significant impact in support of BTS strategic plan and business transformation across the enterprise. Assists the manager...

  • 2nd Class Power Engineer

    Found in: Talent CA C2 - 2 weeks ago

    New Glasgow, Canada MICHELIN Full time

    2nd Class Power Engineer - - - - - - - - - - - - KEY EXPECTED ACHIEVEMENTS • Compliance with EP requirements and safety intervention rules (specific to the boilerhouse, general on the site and in the workshops) • Operation and monitoring of fluids equipment (compliance with conduct protocols, traceability, facilities record tracking, ...) • Fluids...

  • Building Services Engineer

    2 weeks ago

    New Zealand, Canada English Schools Foundation Full time

    Responsibilities: Providing building services engineering input and coordinating with end users, in-house project and facilities management team members, consultants and contractors on M&E system design, installation and maintenance. Quality control for M&E works including supervision and inspection of materials/equipment delivered to site and installation...

  • Building Services Engineer

    1 week ago

    New Zealand, Canada English Schools Foundation Full time

    Responsibilities: Providing building services engineering input and coordinating with end users, in-house project and facilities management team members, consultants and contractors on M&E system design, installation and maintenance. Quality control for M&E works including supervision and inspection of materials/equipment delivered to site and installation...

  • Building Services Engineer

    1 week ago

    New Zealand, Canada English Schools Foundation Full time

    Responsibilities: Providing building services engineering input and coordinating with end users, in-house project and facilities management team members, consultants and contractors on M&E system design, installation and maintenance. Quality control for M&E works including supervision and inspection of materials/equipment delivered to site and installation...

  • Head of Art

    1 day ago

    New Westminster, Canada Offworld industries Full time

    **About Offworld**: Offworld Industries Ltd. (Offworld) is the independent studio behind the successful military first-person shooter game, “Squad”. Offworld was formed in 2014 by more than 15 developers who had worked together on the well known Project Reality mod for Battlefield 2. The founding purpose of the team was to bring a standalone successor of...

  • Shift Engineer

    Found in: Jooble CA O C2 - 4 days ago

    New Glasgow, NS, Canada Michelin Oy Full time

    Compliance with EP requirements and safety intervention rules (specific to the boilerhouse, general on the site and in the workshops) • Operation and monitoring of fluids equipment (compliance with conduct protocols, traceability, facilities record tracking, ...) • Fluids quality, influent parameters and devices compliance (pressure, temperature, water...

  • Auto QA Specialist

    1 week ago

    New Westminster, Canada QHR Technologies Inc Full time

    Position SummaryThe Software Engineering department is looking for a Auto QA Specialist Our Electronic Medical Record (EMR) software Accuro®EMR has the largest adoption in Canada and serves thousands of providers and millions of patients. Our patient platform Medeo leverages that market penetration and connects patients to their healthcare providers. Our...

  • 2nd Class Power Engineer

    4 days ago

    New Glasgow, Canada Michelin Oy Full time

    KEY EXPECTED ACHIEVEMENTS• Compliance with EP requirements and safety intervention rules (specific to the boilerhouse, general on the site and in the workshops)• Operation and monitoring of fluids equipment (compliance with conduct protocols, traceability, facilities record tracking, ...)• Fluids quality, influent parameters and devices compliance...

  • 2nd Class Power Engineer

    8 hours ago

    New Glasgow, Canada Michelin Oy Full time

    KEY EXPECTED ACHIEVEMENTS• Compliance with EP requirements and safety intervention rules (specific to the boilerhouse, general on the site and in the workshops)• Operation and monitoring of fluids equipment (compliance with conduct protocols, traceability, facilities record tracking, ...)• Fluids quality, influent parameters and devices compliance...

  • Roofing Service Technician

    7 days ago

    New Westminster, Canada BC Building Science Full time

    **What we are looking for**: BC Building Science is looking for a Roofing Service Technician to join our team. The main role involves field review of new construction projects. **What we expect from you**: - Working knowledge of a variety of roofing systems and related Building Envelope components and assemblies. - Skilled in technical writing and have...

  • Lead Artist

    2 weeks ago

    New Westminster, Canada Offworld industries Full time

    **About Offworld Industries**: Offworld Industries Ltd. (OWI) is the independent studio behind the successful military first-person shooter game, “Squad”. OWI was formed in 2014 by more than 15 developers who had worked together on the well known Project Reality mod for Battlefield 2. The founding purpose of the team was to bring a standalone successor...

  • Product Support Specialist

    2 days ago

    New Glasgow, Canada J.J. MacKay Canada Limited Full time

    **Product Support Specialist - Overview** This is a full-time salaried position at our corporate headquarters in New Glasgow, Nova Scotia, Canada. The position of Product Support Specialist requires and assumes an individual with an extensive work history that demonstrates a strong and diverse, technical, engineering background and experience. The position...

  • Regular Probationary Faculty

    Found in: Talent CA C2 - 1 week ago

    New Westminster, Canada Douglas College Full time

    The Role The Faculty of Science & Technology currently offers a one-year Certificate in Computing Science, a two-year Computing Science Diploma (with a Game Development stream), an Associate of Science in Computing Science, as well as first- and second-year courses for students transferring to university degree programs. Computing Science is an area of...

  • Automotive Technician

    Found in: Talent CA C2 - 1 week ago

    New Minas, Canada Midas Full time

    At Midas, we are dedicated to providing quality services to customer vehicles in the areas of inspection, diagnosis, and repair utilizing the expertise attained through years of automotive repair experience. You hold a valid and current Certificate of Qualification in the province of Nova Scotia.We are looking for automotive technicians that are able to work...