Senior Quality Assurance Analyst
The Senior Quality Assurance Analyst reports to the Quality Assurance Manager. They act as the Facility Lead Auditor and they are responsible for the internal audit system. They may be assigned investigations, CAPA and improvement projects to ensure that the quality system meets the requirements of the various jurisdictions that Baylis Medical products are marketed. The Senior Quality Assurance Analyst may also coordinate field action activities when they arise or be assigned other special projects.
Snapshot of Responsibilities
- Planning and scheduling for internal audits of the QMS
- Training internal auditors and internal audit team leaders on internal audit process, ISO 19011, ISO 13485 and relevant regulations
- Supporting the execution of internal audits by reviewing and approving checklists, providing consultation on findings and responses and closing out audit findings after correction.
- Planning, implementation and effectiveness of QMS improvement activities
- Facilitation of CAPA to ensure various CAPA elements ( investigations, root cause determination, implementation, and effectiveness) are adequately documented and addressed while ensuring timely completion of all CAPA activities
- Executes field actions
- Investigate, document and recommend corrective actions for QMS process non-conformities
- Assists in the continuous improvement and standardization of quality system procedures and monitors effectiveness
- Reviews and analyses quality data to identify potential improvements
What you bring to the team:
- Minimum Bachelor's degree in a scientific or engineering discipline is required
- 3-5 years quality assurance/ quality engineering experience preferred, in medical device or pharmaceutical industry
- Competence and experience with ISO 13485 Quality System Standard. Experience in U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), Brazil ANVISA, Australian MDR and JPAL/JGMP is preferred.
- Demonstrated successful interdisciplinary collaboration in a team setting
- Strong expertise in analytical methods and continuous improvement methods. Ability to write clearly and informatively technical documentation, correspondence, procedures and work flows.
- Skilled interpersonally; strong communication, negotiation and conflict management skills
- Demonstrated proficiency in project management, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation
- Possible need to travel
- Smart commute options including complimentary shuttle from Kipling Station, and subsidized transit program.
- Flexible working hours that complement core business hours.
- One day off for volunteering, to give back to a charitable organization of your choice.
- Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
- Comprehensive total rewards package, including tuition reimbursement and lifestyle and health spending account.
- Well-being initiatives, including onsite gym facility and fitness classes (yoga and boot camp).
- Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.
At Baylis Medical, everyone works with a shared purpose: to improve the lives of people around the world. Named one of Canada's Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology. Our focus is on providing physicians clinically-relevant tools, so that no patient goes untreated.
We are looking for talented individuals, like yourself, to join Baylis Medical and make an impact in the lives of patients. Are you ready to join us?
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process
While we thank all applicants, only those being considered for an interview will be contacted.
Want an inside look at careers and life at Baylis? View employee profiles on The Muse and follow us on Instagram @Baylismedical
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