Abbott
We are seeking a Senior Product Quality Engineer to join our product development team. This role will serve as a key quality representative, providing expertise in design controls, risk management, and compliance throughout the product lifecycle.
The ideal candidate will have strong experience in the medical device industry, a collaborative mindset, and a deep understanding of regulatory requirements.
Key Responsibilities
Lead and support Design Control activities and ensure timely completion of deliverables Define and review product requirements, ensuring they are measurable and verifiable Support Design Verification & Validation (V&V) planning and execution Lead Risk Management activities, including FMEA, from development through launch Assist in test method development and validation (TMV) Support manufacturing process development and qualification for new products and changes Help define component specifications, sampling plans, and supplier qualifications Support biocompatibility and sterilization qualification processes Participate in internal and external audits and support QMS improvement initiatives Ensure compliance with FDA, EU MDR, and internal quality system requirements Work collaboratively across engineering, manufacturing, regulatory, and supply chain teams Qualifications
Required: Bachelor’s degree in engineering or a related technical field Minimum 5 years of experience in R&D, Manufacturing, or Quality Engineering At least 2 years supporting product development in the medical device industry Experience with risk assessments (FMEA) and test method validation Strong understanding of medical device regulations and standards Preferred: Master’s degree in engineering or technical discipline Experience with active implantable medical devices Knowledge of tools like DOORS, JIRA, or other requirements/risk tracking systems Abbott is an equal opportunities employer and welcomes applications from all qualified candidates. Abbott is committed to providing equal employment opportunities to all employees and applicants, regardless of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
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Lead and support Design Control activities and ensure timely completion of deliverables Define and review product requirements, ensuring they are measurable and verifiable Support Design Verification & Validation (V&V) planning and execution Lead Risk Management activities, including FMEA, from development through launch Assist in test method development and validation (TMV) Support manufacturing process development and qualification for new products and changes Help define component specifications, sampling plans, and supplier qualifications Support biocompatibility and sterilization qualification processes Participate in internal and external audits and support QMS improvement initiatives Ensure compliance with FDA, EU MDR, and internal quality system requirements Work collaboratively across engineering, manufacturing, regulatory, and supply chain teams Qualifications
Required: Bachelor’s degree in engineering or a related technical field Minimum 5 years of experience in R&D, Manufacturing, or Quality Engineering At least 2 years supporting product development in the medical device industry Experience with risk assessments (FMEA) and test method validation Strong understanding of medical device regulations and standards Preferred: Master’s degree in engineering or technical discipline Experience with active implantable medical devices Knowledge of tools like DOORS, JIRA, or other requirements/risk tracking systems Abbott is an equal opportunities employer and welcomes applications from all qualified candidates. Abbott is committed to providing equal employment opportunities to all employees and applicants, regardless of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
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