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Quality Assurance Specialist
2 months ago
At Abbott, we are seeking a highly skilled Quality Assurance Specialist to join our team in Oslo, Norway. As a key member of our Cardiometabolic and Informatics Business Unit, you will be responsible for ensuring the quality of our purchasing controls and ensuring they meet our quality and business objectives.
Key Responsibilities- Compliance with Business Policies: Ensure all duties are carried out in compliance with established business policies and procedures.
- Quality Process Development: Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
- Professional Behavior: Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Quality Awareness: Maintain awareness of the quality consequences that may occur from the improper performance of their specific job.
- Supplier Management: Select, qualify, and monitor suppliers, including maintenance of the Approved Supplier List (ASL), monitor supplier performance, qualify potential suppliers, and oversee supplier corrective action records (SCARs).
- Regulatory Compliance: Apply QSR 21 CFR Part 820 (Medical Devices) and ISO13485 to everyday application of Supplier Quality Management activities.
- Quality Agreements: Support the creation and management of quality agreements with suppliers.
- Supplier Change Control: Manage supplier change control and work with cross-functional teams to evaluate the change impact to product performance.
- Purchasing Controls: Support and complete purchasing controls related QI and CAPA according to local procedures.
- Training and Development: Responsibility for specific tasks will be reflected in the employee's training plan.
- Additional Responsibilities: Perform other duties and projects as assigned.
- Education: Bachelor's degree in Life Science or engineering discipline.
- Background Check: IF APPLICABLE: Approved and valid background check from the Norwegian Civil Aviation Authority.
- Advanced Education: Master's degree in life science or engineering discipline.
- Regulated Environment Experience: A minimum of 2 years' experience from regulated environment (medical devices and/or pharmaceutical) is required (ISO 13485, cGMP).
- Regulatory Knowledge: Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, ISO 13485, ISO 14971:2012).
- Root Cause Analysis: Experienced in root cause analysis and corrective action processes.
- Communication Skills: Excellent written and verbal communication skills (both Norwegian and English).
- Organizational Skills: Ability to organize and prioritize workflow and to meet established timeframes.
- Analytical Skills: Excellent analytical and problem-solving skills (root cause analysis, risk analysis).
- Teamwork: Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives.
