Engineer, Sr. Quality Assurance

Abbott • Plano, TX

3d • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

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 in a highly matrixed and geographically diverse business environment.
• 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.
• Six Sigma certification (e.g., ASQ CQE, CQA or Six Sigma certification preferred).

Responsibilities

• Analyze Quality System data and present established metrics to senior and executive 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.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

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.

What This Job Offers

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