Senior Quality Engineer Medical Device jobs

Join one of Canada’s largest, fastest growing suppliers of control label products. CRL Synergy is seeking a Senior Pharmaceutical Quality Assurance (QA) Manager who can thrive in a fast-paced environment that involves working in an office team environment. Providing quality products to the consumer is paramount to the business.

The QA Manager will provide quality assurance and technical support through testing, data collection and analysis. The successful candidate will be required to audit process documentation and identify quality assurance issues and analyze data to reduce risks.

Responsibilities include:

• Strong understanding of GMP.
• To actively participate in projects with the Engineering team, Technical team and GMP Operations for drugs, medical devices, natural health products and cosmetics
• Generate, review, and approve GMP documentation such as Standard Operating Procedures, non-conformance reports, Out of specification results.
• Ensuring that documentation, complaints, deviations, non-conformances, investigations, corrective, and preventative actions, and change control are performed according to quality and regulatory requirements.
• Assisting in updating methods and procedures (SOPs) related to production, pest control, building, equipment, packaging, labeling and storage and distribution of products.
• Ensuring accurate record keeping and filing as per organizational procedures.
• Ensuring efficiency of a Quality Management System for all operational activities.
• Monitoring process control points and taking measures to eliminate deviations.
• Performing audits and analysis of shelf life projects through testing, report preparation and providing final summaries and recommendations.
• Acting as Team Lead for all third party audits (including Health Canada).
• Managing all Pharmacovigilance programs.
• Managing customer complaints and ensuring appropriate actions and preventative measures are in place to prevent reoccurrence.
• Handling clerical, administrative, technical or customer support issues.
• Providing training, coaching and mentoring to team members as required.
• Other duties as assigned.

Specific skill requirements:

• Diploma/Bachelor’s Degree in a science related field from a Canadian institution is required.
• Excellent time management skills and ability to multi-task efficiently and prioritize work.
• Attention to detail and processes.
• Excellent written and verbal communication skills.
• Strong organizational, planning and problem solving skills.
• Efficient with computers and computer programs; proficient in MS Office suite of products.
• Knowledge of good manufacturing practices; experience in GMP environment is an asset.
• Proven track record of success in a high-pressure, fast-paced environment with changing multiple priorities and frequent interruptions.
• Able to work individually or as part of a team.
• Customer focused.

Job Types: Full-time, Permanent

Benefits:

• Dental care
• Extended health care
• On-site gym
• On-site parking
• Tuition reimbursement
• Vision care

Education:

• Bachelor's Degree (required)

Experience:

• quality assurance: 1 year (preferred)

Work Location: In person