Supervisor Quality Assurance

Abbott•Westford, MA
•$61,300 - $122,700•Onsite

About The Position

Abbott is seeking a Quality Assurance Supervisor I for its Vascular division in Westford, Massachusetts. This first-line supervisory role leads approximately 10 quality inspectors and technicians who support receiving, in-process, and final inspection activities, as well as tool inspections and qualifications and first article inspections. The supervisor oversees operational implementation of quality assurance strategies and regulations, assesses potential risks, ensures compliance, and makes recommendations to management. The role is fully onsite and includes approximately 10% travel. The supervisor provides day-to-day leadership, coaching, and development for the team; assigns work, monitors performance, and ensures staffing and inspection coverage meet production requirements. The role assures timely inspections supporting materials and product releases, maintains staff and equipment capabilities, monitors inspection procedures and regulatory compliance, and supports communication and collaboration with other departments. The supervisor also supports continuous improvement and company initiatives related to Quality Management Systems, Environmental Management Systems, and other regulatory requirements.

Requirements

  • Associate's degree in an Engineering field or an equivalent combination of education and work experience.
  • Minimum 5 years of quality supervisory experience in the medical devices or pharmaceutical industry.
  • 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 communication skills, including the ability to communicate effectively at multiple organizational levels.
  • Ability to multitask, prioritize, and meet deadlines in a timely manner.
  • Strong organizational and follow-up skills, with attention to detail.

Nice To Haves

  • Bachelor’s degree.
  • Quality systems auditing experience.
  • Experience working in a broader enterprise/cross-division business unit model.
  • SAP experience.
  • ASQ certification in quality, Six Sigma, and/or lean manufacturing.

Responsibilities

  • Provide day-to-day leadership, coaching, and development for quality inspectors and technicians.
  • Assign work, monitor performance, and support employee development.
  • Ensure staffing and inspection coverage meet production requirements.
  • Assure timely inspections supporting materials, product releases, and in-process inspections.
  • Maintain staff and equipment to assure appropriate technical capabilities.
  • Monitor inspection procedures for effectiveness and compliance with appropriate regulatory standards.
  • Communicate with and provide support to other departments as necessary.
  • Maintain a department culture of continuous improvement.
  • Support company initiatives and comply with Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
  • Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors.
  • Oversee quality assurance implementation, assess potential risks, ensure compliance, and make recommendations to management.
  • Facilitate audits and regulatory inspections and liaise with external vendors, contractors, or suppliers to ensure their products or services meet quality standards.

Benefits

  • Career development opportunities with an international company.
  • Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • Retirement savings plan with high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit.
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