Principal and Sr QE's

Billerica, Massachusetts Quality Engineering 398 days ago

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Summary

Principal & Sr Quality Engineers with expertise in Process Validation, Computer Software Validation (CSV), Process Characterization, Test Method Validation (TMV), and Equipment Qualification.

Job Requirements

  • Experience with validation skills (IQ, OQ, PQ, TMV, CSV, Equipment Validation)
  • Expertise in manufacturing process improvements
  • Proficiency in updating pFMEA
  • Experience using data/KPIs/Metrics and systems like MOS, CAP, and Lean Sigma
  • Experience working with disposable medical devices or capital equipment is ideal
  • Work is 100% onsite

Preferred Skills

  • Strong knowledge of quality standards and protocols for processing materials
  • Proficiency in statistical analysis to assess product and material compliance
  • Familiarity with inspection and testing mechanisms and equipment
  • Ability to collaborate with engineering and manufacturing functions

Job Responsibilities

  • Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products
  • Collaborate with engineering and manufacturing to ensure quality standards are in place
  • Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment
  • Design or specify inspection and testing mechanisms and equipment
  • Conduct quality assurance tests and perform statistical analysis to assess the cost and responsibility for non-compliant products or materials
  • Ensure corrective measures meet acceptable reliability standards and documentation is compliant with requirements
  • Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality


Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
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