Sr. Director Quality Engineering

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• 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 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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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
• An excellent retirement savings plan with high employer contribution
• Career development with an international company where you can grow the career you dream of

Sr. Director, Quality Engineering:

MAIN PURPOSE OF ROLE:

This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

MAIN RESPONSIBILITIES:

• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide high level direction of all activities related to non-device software quality in accordance to policy including software validations .
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• 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.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Provide high level direction of all activities related to calibration of measurement equipment used throughout the organization in accordance to policy, including equipment traceability, out of tolerance management, and interval management.
• Provide high level direction of all activities related to incoming inspection of supplied product in accordance to policy, including first article inspection, non-conforming material review, acceptance testing, segregation of material and MRP transactions.
• Be an effective member of the cross-functional Director organization to foster continuous quality compliance, cost, and predictive measures improvements.
• Provide diligent and fact-based communication to Executive Management team, peers, and team.
• Provide overall functional Quality leadership which may include: Supplier Assurance, Metrology, Software Quality
• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.
• Provide management and development of the Quality staff.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Define and communicate overall vision and cascaded objectives for the departments.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Provide influential leadership with global sites to drive proactive quality improvements.

QUALIFICATIONS:

Education Level

Bachelors Degree in a Related field (± 16 years)

An equivalent combination of education and work experience

Masters Degree (± 18 years)

Preferred

Experience/Background:

Experience Details

Minimum 15 years

In quality desired with at least 7 years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment.

Class III or II medical device background.

Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.

Ability to travel Internationally to support International manufacturing sites.

Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired.

Strong project management, team skills, and influential management also highly desired.

Six Sigma Black Belt desired.

Experience working in a broader enterprise/cross division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Ability to work effectively within a team in a fast-paced changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multi-tasks, prioritizes and meets deadlines in timely manner.

Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Licenses and Certifications:

License/Certification

Language Proficiency:

Language

Proficiency

Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.

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• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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