Quality System Engineer
About The Position
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. What You’ll Work On Analyze Quality System data and present established metrics to management. Investigates and resolves quality system corrective actions and preventive actions. Support internal and external audits. Works with cross functional teams to develop sound quality improvement plans that effectively consider the impact of change(s) and the actions required for implementation. Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. As appropriate, utilizes Lean, Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process. Analyzes quality audit findings and recommends modifications in products and processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
Requirements
- Bachelor’s Degree in Engineering or Technical Degree or an equivalent combination of education and work experience.
- 3+ years’ experience in the ownership of CAPA process, to include conducting root cause investigations and developing action plans/effectiveness checks.
Nice To Haves
- Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
- Multitasks, prioritizes, and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Advanced computer skills, including gap analysis and report writing skills.
- Detailed knowledge of FDA, GMP, and ISO 13485.
Responsibilities
- Analyze Quality System data and present established metrics to management.
- Investigates and resolves quality system corrective actions and preventive actions.
- Support internal and external audits.
- Works with cross functional teams to develop sound quality improvement plans that effectively consider the impact of change(s) and the actions required for implementation.
- Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- As appropriate, utilizes Lean, Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
- Analyzes quality audit findings and recommends modifications in products and processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
