Quality Assurance Manager

Abbott • Westfield, MA

6h • Onsite

About The Position

The Quality Assurance Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

Requirements

• B.S. in Engineering or related field ; or equivalent combination of education and work experience.
• 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.
• 3-5 years in a supervisory/leadership role.
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.
• Demonstrated and impactful strong project management and people leadership skills required.
• 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.

Nice To Haves

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

Responsibilities

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Interacts with internal and external stakeholders, by meeting regularly, responding to requests and explaining procedures as applicable.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translates department goals into individual objectives and KPI.
• Identifies, develops and implements processes to improve department performance.
• Monitors departmental activities and records to ensure compliance.
• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• May also direct work assignments for quality control auditors.
• May also direct Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & engineers.
• May own, author, review, approve, and support CAPA activities.
• Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc).
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
• Promotes the attainment of group goals by selecting, motivating, and training capable staff.
• Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
• Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability.
• Carries out operations within an established budget.
• Makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve site commitments and program objectives established by senior management.
• Investigates and solves problems that impact work processes and personnel within the assigned unit.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with 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: Manager