Quality Engineer, Medical Device and Pharmaceutical Packaging

2 weeks ago

Canada And Medisca Inc. Full time
Quality Engineer, Medical Device and Pharmaceutical Packaging

Job Category : Engineering

Requisition Number : QUALI001475

Apply now

  • Posted : August 21, 2023
  • Full-Time
Locations

Showing 1 location

Description

At Medisca, we are a leading organization in the compounding pharmaceutical industry. We are dedicated to delivering high-quality products that meet the highest standards of safety and compliance. Our collaborative and innovative work environment fosters teamwork, creativity, and continuous learning. We value diversity and believe in the power of collaboration to drive success. Join our team and contribute your expertise to our mission of providing exceptional quality products to improve patient care.

We are seeking a highly skilled and experienced Quality Engineer to join our team to support the medical device and pharmaceutical packaging product category expansion. As a Quality Engineer at Medisca, you will play a crucial role in ensuring the successful transfer of products from production design and development to manufacturing and commercial standards. Your expertise will be instrumental in maintaining regulatory compliance, establish product quality control standards, implementing quality improvement initiatives.

Responsibilities:

  • Collaborate with cross-functional teams to ensure the successful transfer of products from production design and development to manufacturing and commercialization.
  • Develop and maintain quality control plans and specifications for sterile and non-sterile products in collaboration with R&D Engineering, Quality and Product Development teams.
  • Liaise with device and packaging manufacturers to review and/or establish manufacturer Quality Inspection Documentation
  • Write technical documentation related to quality control, such as quality inspection document and quality control test protocols.
  • Developing and qualifying new testing methods using measurement system analysis methodologies, such as gauge repeatability and reproducibility (gauge R&R).
  • Collaborate with manufacturing teams to resolve quality-related issues, implement corrective and preventive actions (CAPAs), and drive root cause analysis.
  • Perform risk assessments and develop risk mitigation strategies to ensure product safety and reliability.
  • Develop and maintain quality metrics and reports to monitor performance, identify trends, and drive continuous improvement initiatives.
  • Stay updated with industry trends, regulations, and advancements in quality engineering practices to ensure compliance and drive innovation.
  • Performing inspections on incoming components and in-process products as required.
  • Give technical guidance to Quality Inspectors, or other quality staff assigned to work on common projects
  • Proactively investigates, identifies, and implements best-in-class quality practices.
  • Review and approve process design documents, such as process validation and process control
  • Review and approve manufacturing documents such as instructions, protocols, test methods, and process changes
  • Demonstrate company values, work with integrity and be a supportive team member.

Qualifications:

  • Bachelor's degree in Engineering or a related field.
  • Five (5) to Seven (7) years' experience in Quality Control and/or Quality Assurance in the medical device and/or pharmaceutical packaging industry.
  • Strong knowledge of quality management systems, regulations (ISO 13485, FDA QSR, etc.), and industry standards (ISO 11607, ASTM, etc.) in different regions (Canada, US, Australia, Europe)
  • Experience in Product Development considered a strong asset
  • Experience in Regulatory/Compliance of Medical Devices considered an asset
  • Proven track record of successfully transferring products from production design and development to manufacturing and commercial standards.
  • Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
  • Strong communication and interpersonal skills in French and English, with the ability to collaborate effectively with cross-functional teams in our global offices.
  • Detail-oriented and highly organized, with the ability to manage multiple projects and priorities simultaneously.
  • Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.

Join our team and contribute your expertise to our mission of delivering high-quality products that improve patient care. This is an exciting opportunity to be part of a dynamic and innovative organization that values excellence and continuous improvement.

What's in it for you...

We invest time and resources into making sure Medisca is as good as the people we hire.

  • Work/Life Balance hour workweek with early Fridays all year long, PTO and vacation policy
  • Invest in your health – Choice of modular plans, health spending account and free Telemedicine

Your well-being is important – Wellness program offered

  • Flexible work environment – Hybrid work schedule with home office reimbursement program
  • Your Future is Bright – Opportunities to learn and grow within Medisca
  • Save for your Future – Medisca contributes to a deferred profit sharing plan (DPSP) when you invest in RRSPs
  • Help us grow – Employee Referral Program
  • Central location - Free parking/accessible by public transportation; a commercial center is within walking distance for lunch or groceries
  • We like to have fun – company events throughout the year
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