Supervisor Quality Assurance

Abbott; Westford (MA); On-site; USD 61,300 - 122,700; Full time

Job summary

Abbott in Westford, MA seeks a Quality Assurance Supervisor I to lead a team of about 10 inspectors and technicians across receiving, in-process, and final inspections in a fully onsite setting.

You will ensure compliance with FDA regulations and QMS/EMS, drive continuous improvement, and collaborate with suppliers and internal partners to maintain quality standards. A Bachelor's degree is preferred with 5+ years of supervisory experience in medical devices/pharma.

Qualifications

• Minimum 5 years quality supervisory experience in medical devices or pharmaceutical industry.
• Experience with quality systems auditing and regulatory compliance.
• Ability to work in a matrixed, geographically diverse environment.

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.

Skills

Leadership

Coaching

Regulatory knowledge

Quality systems

Education

Associate's degree in Engineering

Bachelor’s degree preferred

Tools

SAP

Job description

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.

Job Title

Quality Assurance Supervisor I

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 :

• Career development with an international company where you can grow the career of which you dream.
• 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.
• 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.
• 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.

The Opportunity

We are seeking a Quality Assurance Supervisor I for our Vascular division in Westford, MA.

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.

Core Job 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.

Education and Experience You'll Bring

Required :

• Associate's degree in an Engineering field or an equivalent combination of education and work experience. Bachelor’s degree preferred.
• 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.

Preferred

• SAP
• ASQ certification in quality, six sigma, and/or lean manufacturing is desired.

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.