Quality Assurance
4 weeks ago
**The Big Picture**
The Quality Excellence & Assurance Team Leader plays a crucial role in leading the quality team to uphold and enhance quality standards in alignment with regulatory and company requirements. This role combines hands-on leadership with strategic project management, requiring mature quality assurance knowledge for planning, conducting, and overseeing quality initiatives. The Team Leader drives continuous improvement, ensures compliance with new and updated standards, and fosters a culture of quality throughout the organization.
**Impact Through Innovation**
- Per Senior Quality Assurance Analyst, with the following key responsibilities:
- Leads the execution and continuous improvement of quality systems, policies, and objectives, ensuring alignment with regulatory standards and company goals. Utilizes continuous improvement methodologies to enhance the quality management system. Directly supervises quality team members, fostering their development and ensuring the team is well-resourced and competent.
- Oversees quality excellence and assurance functions, including CAPA, product final release, complaints, internal audits, standards compliance, etc.
- Coordinate and collate key performance indicators of the quality system, providing insight into operational efficiency and product quality.
- Undertakes independent studies, analyses, interpretations, and conclusions to assess compliance with new or changed standards and regulations.
- Ensure the adequacy of training in Quality Assurance; ensuring the training for the quality management system is up to date and effective.
- Coordinate and lead significant investigations, especially escalations of performance issues with customers; interface with engineering and production on quality-related issues in quality system processes.
- Participate in internal audits as an audit team leader; participate in supplier audits as an audit team leader; participate in external audits.
- Promotes a quality culture and works closely with other departments (operations, supply chain, manufacturing, regulatory, R&D, sales, etc.) to build strong cross-functional relationships.
- Leads project planning and continuous improvement initiatives in collaboration with departments, aiming to enhance operational efficiency and product quality. Support implementation of any Quality System updates; Participate in the development of a strategic vision for projects
- Plan and review the work of the quality team, conduct employee evaluations and career development planning and conduct some administrative management functions (e.g., vacation request approvals). Supervision may call for recommendations concerning the selection, training, rating, and discipline of staff.
- Adhere to and promote adherence to all Corporate, Quality, and Health and Safety policies and procedures.
- Perform other duties as required.
**Your Unique Expertise**
**Required skills**:
- 5-8 years of related working experience and minimum 2 years of leadership experience
- A Bachelor's Degree in Engineering or a related field of Science.
- Training or certification in the Quality field.
- Demonstrated competence as a Senior Quality Assurance Analyst or equivalent.
- Strong leadership and interpersonal skills.
- Proficient in Statistical and Analytical Techniques.
- Demonstrated competence in ISO 13485, ISO 14971, 21 CFR 820, CMDCAS and EU MDR, other relevant jurisdictional regulations, and ISO 19011.
- Proficient in MS Office.
- Excellent analytical and communication skills (presentation, written and oral).
- Excellent organization and time management skills.
- Demonstrated proficiency in project management.
- Some travel required.
**Our Distinctive Edge**
- Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
- Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
- Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
- Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
- Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
- Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.
**Our Impact**
Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.
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