Senior Quality Engineering Manager leading acquisition lifecycle and quality processes at Medtronic. Supporting Operating Units with due diligence, integration planning, and continuous improvement initiatives.
PI
Hybrid Quality Assurance Associate
Posted 1 hour ago
About the role
- Quality Assurance Associate at Prollenium focuses on compliance and documentation for medical devices. Responsible for audits, QMS training, and supplier evaluation in a hybrid work environment.
Responsibilities
- Provide prepared documentation in support of audits and inspections from regulatory agencies ie. Health Canada, US FDA, Brazilian, European, UK, Australia, Japan
- Assist in requesting Quality Metrics from PMT Depts for discussion during Management Review
- Support the validation program by issuing validation report numbers, change control forms and obsolescence of older versions within the QMS
- Edit and save SOPs as needed
- Assist in coordinating PMT’s company-wide training program
- Accession new customer complaints, collect information, prepare reports, submit within required timeframes
- Develop and maintain documentation to ensure compliance for critical and non-critical suppliers (certificates, contracts/agreements, supplier audits, and corrective actions)
- Maintain retrievable records (paper and/or electronic) of lower level inventory items
- Fill paperwork as per GMP requirements
- Participate in releasing lower-level inventory items using PMT’s ERP system
- Participate in statutorily required meetings related to company health and safety policies
Requirements
- 1 - 3 or more years of work experience in a Quality Assurance function in an ISO 9001, 13485 or 17025 environments
- University degree in the science (chemistry, biology, pharmacy or similar)
- Excellent written and oral communication skills
Benefits
- Competitive compensation
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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