Senior Supplier Quality Specialist (Point of Care) - Ottawa

Abbott • Ottawa, ON

7d • CA$99,750 - CA$146,300 • Hybrid

About The Position

This position is based at our Ottawa office within the Point of Care division and requires on‑site presence four days per week, with the option to work remotely one day. As the Senior Supplier Quality Specialist, you’ll have the chance to support the selection, approval and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. You will participate in the audits of manufacturing, supplier/Third Party Manufacturers and commercial affiliate sites. Other responsibilities include managing and or participating in initiatives/projects that are cross functional/ cross divisional in scope as Subject Matter Expert (e.g., due diligence, regulatory readiness, etc.).

Requirements

• Completed bachelor's degree, in Engineering or STEM related field preferred.
• Four years of relevant experience of Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries.
• Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD.
• Knowledge in the areas of design controls, verification and validation activities, manufacturing practices and statistical techniques.
• Experience in conducting external quality assessments.
• Certified Lead Auditor trained, is preferred.

Responsibilities

• Ensure compliance to applicable Regulatory, Division, Site and Corporate policies and procedures.
• Identify and promptly communicate compliance risks against current standards/regulations so that they are understood.
• Provide guidance in the planning and execution of Quality System improvements.
• Ensures that the division’s approved supplier list is maintained and accurate.
• Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required.
• Communicates division’s approval requirements to supplier and monitors feedback per project timelines.
• Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
• Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab.
• Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate.
• Leads in the evaluation and approval of supplier requested changes or improvements. This activity may also include the identification and/or approval of a new supplier to provide an alternate material.
• Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits).
• Provide leadership and mentor audit team colleagues, provides oversight to one or more junior level auditors.
• Technically proficient and has the ability to understand when technical issues affect product quality.
• Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.
• Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.
• Monitors supplier performance and reports supplier quality trend data.
• Drives improvement projects, as required, to improve supplier performance.
• Assists in the preparation of area metric data for delivery to Sr. Management.
• Recommends areas for supplier improvement, as appropriate.
• Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program.

Benefits

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior