Quality Assurance Manager

Abbott; Westfield (IN); On-site; USD 99,300 - 198,700; Full time

Job summary

Abbott is seeking a Quality Assurance Manager in Westfield, IN, to head its Quality Operations Organization. This role includes leading a team to support manufacturing, ensure compliance with regulatory standards, and enhance quality systems.

The ideal candidate will have 8-10 years of experience in a manufacturing support role and demonstrate strong leadership and project management skills. Abbott offers an inclusive work environment and opportunities for professional growth.

Qualifications

• 8-10 years in manufacturing support environment in quality.
• 3-5 years in a supervisory/leadership role.
• Strong project management and people-leadership skills.

Responsibilities

• Lead quality operations and support manufacturing.
• Monitor compliance with regulatory requirements.
• Develop direct reports through training and performance reviews.

Skills

Leadership skills

Project management skills

Technical knowledge in quality systems

Communication skills

Organizational skills

Education

B.S. in Engineering or related field

Tools

Quality management tools

CAPA systems

Job description

Quality Assurance Manager

Location: Westfield, IN. Division: Structural Heart.

Job Summary

The Quality Assurance Manager is accountable for the Quality Operations Organization and leads a team of quality professionals to support manufacturing, supplier development, new product development, distribution/warehouse, and quality systems. The manager directs projects to ensure the manufacture of high‑quality products and compliance with regulatory requirements.

Key Responsibilities

• Implement staffing plans by identifying resource requirements, writing justifications for additional personnel, obtaining approvals, and coordinating recruitment with Human Resources.
• Develop direct reports by providing training, assigning challenging tasks, applying disciplinary action as appropriate, and conducting performance reviews.
• Monitor daily operations and provide direction to employees to achieve unit or project goals.
• Interact with internal and external stakeholders, meet regularly, respond to requests, and explain procedures.
• Interpret and execute policies that affect work processes and personnel within the assigned unit.
• Contribute to the development of operational policies and procedures for the unit.
• Monitor compliance with company policies and regulations such as FDA, BSI, EEO, etc.
• Contribute to budget development and monitoring through cost analysis.
• Translate department goals into individual objectives and KPIs.
• Identify, develop, and implement processes to improve department performance.
• Monitor departmental activities and records to ensure compliance.
• Support manufacturing by defining work assignments to address process defects and implement improvements using Quality System tools.
• Direct work assignments for quality control auditors.
• Support new product development by defining projects focused on new products/processes in coordination with management, project leaders, and engineers.
• Own, author, review, approve, and support CAPA activities.
• Engage and escort internal and external auditors (BSI, FDA, KGMP, etc.).
• Improve Quality Systems and tools by gathering data, identifying weaknesses, and researching/selecting new tools.
• Maintain quality system capability by working on quality system issues and delegating project work.

Influence / Leadership

• Promote attainment of group goals by selecting, motivating, and training capable staff.
• Provide leadership to assigned units by communicating and guiding toward group objectives.

Planning / Organization

• Schedule human and material resources within a group or section to ensure availability.
• Carry out operations within an established budget.

Decision Making / Impact

• Express assignments as tasks and objectives.
• Make day‑to‑day decisions within guidelines to achieve site commitments and program objectives.
• Understand that erroneous decisions can result in serious delays, resource waste, and financial impact.

Required Qualifications

• B.S. in Engineering or related field; or equivalent education and work experience.
• 8–10 years of increasing responsibility, impact, and scope within a manufacturing support environment in quality.
• 3–5 years in a supervisory/leadership role.
• Demonstrated performance in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Technical knowledge of monitoring progress of individuals and teams toward departmental goals; monitoring costs and resources; monitoring external environment; and proficiency in a quality system environment.
• Ability to develop new work processes, improve human and material resource utilization, and facilitate continuous‑improvement programs.
• Strong project management and people‑leadership skills.
• Ability to work in a highly matrixed, geographically diverse business environment.
• Strong leadership skills, including goal setting and constructive feedback.
• Ability to work effectively within a team in a fast‑paced changing environment.
• Excellent verbal and written communication at multiple organizational levels.
• Ability to multi‑task, prioritize, and meet deadlines.
• Strong organizational, planning, and follow‑up skills and accountability.

Preferred Qualifications

• Class II or III medical device experience or comparable regulated industry experience.
• Six Sigma Black Belt.
• ASQ Certified Quality Engineer.
• Industry certification.
• Experience in a broader enterprise/cross‑division business unit model.

Salary range: $99,300.00 – $198,700.00.

Abbott is an Equal Opportunity Employer, committed to employee diversity.