Quality Control Specialist

Quality Control Specialist (Full-time Position)

BioMedica Diagnostics, a member of the Scotia Investments Family of Companies, is helping people live better lives. It’s more than our vision; it’s what we do. With products and technologies in over 70 countries, BioMedica brings innovation, quality, and affordable diagnostic solutions to an ever-growing group of international partners focused on helping to improve patient outcomes in the fields of Haemostasis and Thrombosis. By collaborating with global researchers and practitioners we help drive progressive health care by bringing diagnostic products and technology to the forefront of medical research in human and animal health.

We are actively seeking a Quality Control Specialist to fill a full-time role. Reporting to the Quality Control Manager, this is a great opportunity for a hands-on and multi-skilled individual capable of working both independently and as part of dynamic team. BioMedica has experienced significant change and growth in recent years and is seeking an individual who is interested in actively contributing to the continued success of our Quality Control team.

Responsibilities:

• Verify through testing that all manufactured products conform to a defined set of quality criteria to ensure consistency and compliance with approved specifications.
• Adhere to Good Manufacturing Practices (cGMP), ISO13485:MDSAP, and IVDR regulations.
• Review Quality Control documentation and test results to ensure that products meet specifications.
• Adhere to and execute equipment maintenance schedules.
• Trend and evaluate product performance data to identify failure risks in established processes and procedures.
• Inspect and release incoming materials as required.
• Maintain testing documentation under established quality system procedures.
• Generate Certificates of Analysis for finished products.
• Conduct technical investigations and root cause analyses to support product manufacturing and complaint handling.

Required Education and Competencies:

• BSc. in Biology, Chemistry, related discipline, or a medical laboratory designation
• Minimum 3 years experience working in a regulated laboratory setting; experience in analytical testing/medical device industry is preferred
• Related experience working in a research or production setting would be considered
• Scientific aptitude to base decisions on objective data
• Excellent time management skills and ability to manage multiple tasks simultaneously; ablility to adapt to changing priorities while completing tasks on time
• High organizational ability
• Excellent oral and written communication skills
• Strong teamwork and collaboration abilities
• Competent with Microsoft Office

Skills considered an asset:

• Experience running and maintaining analytical equipment such as coagulation analyzers, spectrophotometers and microplate readers
• Previous experience working within a QMS system such as, ISO 13485 or CLIA regulations
• Experience with Accpac/Sage software
• Experience in healthcare, medical device, or similar regulated industry

Benefits of Working at BioMedica Diagnostics:

• Company culture focused on honesty, commitment, quality, and integrity
• Excellent opportunity for career development and growth
• Competitive compensation structure
• Comprehensive pension and benefits plan

Job Types: Full-time, Permanent

Salary: $46,000.00-$58,000.00 per year

Benefits:

• Company events
• Company pension
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Commute:

• Windsor, NS B0N 2T0 (required)

Work Location: In person

Application deadline: 2024-03-15