Senior Quality Engineer

A great opportunity to work with a well known medical device company!

Responsibilities:

• Develop and maintain risk management files and pFMEAs for new processes and process changes.

• Support validations for new and existing products, processes and equipment.

• Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.

• Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc…

• Manage and support batch record review and disposition of product.

• Support and prepare for site-level internal, external, supplier and customer audits.

• Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.

• Identify and implement opportunities for continuous improvement.

• Interact and coordinate activities with other departments, external vendors and customers.

• Perform other Quality System related duties as required.

Qualifications:

• Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).

• 5+ years of experience in roles with increasing levels of complexity and scope.

• Experience in an FDA regulated manufacturing or industrial environment.

• Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.

• Technical skills and experience related to process validation, statistical methods, and risk management.

• Experience performing quality audits.

• Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.

• Strong cross-collaborator, effective coaching and mentoring skills

Experience Level

Intermediate

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.