Quality Engineer

Work Location:

Danvers, Massachusetts | Shift: No | Department: LS-SC-UDQEA Danvers Mobius Quality Engineering | Recruiter:
Michelle Cole

The Quality Engineer in Danvers, MA, is crucial to the success of both the Quality and Manufacturing teams at our production site.

• Utilize root cause analysis tools to complete product and process related investigations
• Lead and support risk assessments utilizing FMEA
• Review and improve standard operating procedures and other production documentation
• Support customer‑facing improvement projects that incorporate evolving customer and industry requirements
• Conduct internal GMP and ISO audits
• Support deviation resolution in production and corrective action implementation
• Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP, and Millipore Sigma standards
• Monitor and trend process performance and drive continuous improvement
• Lead projects with cross functional teams to improve in‑process quality, reduce customer complaints, and increase production efficiency

• Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or other Engineering discipline OR in Biology, Chemistry, or other Life Science discipline

• 1+ year of experience in Biotechnology, Pharmaceutical, Medical Device, or Life Science industries
• Lean Six Sigma and/or root cause analysis training
• Experience leading risk assessments using tools such as FMEA
• Experience with Quality Systems (e.g. Deviation, CAPA, Change Control, Documentation Management)
• Experience conducting internal/customer/supplier audits
• Demonstrated ability to write and execute test protocols and reports
• Demonstrate strong quality knowledge: GMP/GDP, ISO standards

Pay Range for this position: $67,200 - $123,100 / annually. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

For more information .

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.