Supervisor Quality Assurance

Abbott • Westford, MA

12d • $61,300 - $122,700 • Onsite

About The Position

The Quality Assurance Supervisor I provides leadership to inspectors and technicians that support receiving, in-process and final inspection, tool inspection/qualifications and first article inspections. Oversees operational implementation of quality assurance strategies and regulations. Completes the assessment of potential risks, ensures compliance and gives recommendations to management. Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards. This is a first-line supervisory position responsible for leading a team of approximately 10 inspectors and technicians in support of receiving, in-process, and final inspection activities. This role is fully onsite.

Requirements

• Associate's degree in an Engineering field or an equivalent combination of education and work experience.
• Minimum 5 years quality supervisory experience in medical devices or pharmaceutical industry and quality systems auditing experience 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.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Bachelor’s degree preferred.
• SAP
• ASQ certification in quality, six sigma, and/or lean manufacturing is desired.

Responsibilities

• Provides day-to-day leadership, coaching, and development for a team of quality inspectors and technicians.
• Assigns work, monitors performance, and supports employee development.
• Ensures staffing and inspection coverage meet production requirements.
• Assure timely inspections that support materials, product releases and in-process inspections.
• Maintain staff and equipment to assure appropriate technical capabilities.
• Monitor inspection procedures for effectiveness.
• Monitor compliance to appropriate regulatory standards.
• Effectively communicate with and provide support to other departments as necessary.
• Maintain a department culture of continuous improvement.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• 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.

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 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: Mid Level
• Education Level: Associate degree