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Quality Engineer II

Quality Engineer II

Planet PharmaBillerica, MA, United States
8 days ago
Job type
  • Full-time
Job description

Job Description

Top 3 technical skills that are required for the role :

1. Experience working in a clean room or regulated manufacturing environment.

2. 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.

3. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions

Education Required & Years' Experience Required :

Requires a University Degree and minimum of 3 years of experience.

Quality Specialist - Medical Device Industry

Seeking a professional with 3+ years' experience in medical device quality management, including NCMR, CAPA, and process validation. Requires strong knowledge of FDA (21 CFR Part 820), ISO 13485, EU MDR, and related regulations. Proven ability to lead NCMR and CAPA processes.

Day-to-Day Responsibilities :

  • Partner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances (NCs) and potential NCs
  • Conduct quality line walks to ensure compliance and audit readiness
  • Own and collaborate on Quality Management System (QMS) and Process change orders
  • Represent Quality in process improvement projects
  • Collaborate with cross-functional teams to resolve quality issues
  • Ensure corrective actions and documentation meet regulatory and internal standards

TECHNICAL SKILLS

Must Have

  • 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
  • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
  • Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
  • Strong project management skills, with the ability to manage multiple priorities and deadlines.
  • Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
  • Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
  • Proficiency in Microsoft Office Suite and quality management systems (QMS).
  • Strong technical writing capability. Experience in Process Validation.
  • Experience working in a clean room or regulated manufacturing environment.

    • Nice To Have

  • DMAIC, process mapping, 5 Whys, Is / Is Not analysis - scientific problem-solving methodologies
  • Experience with Agile Map change control systems
  • Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES)

    • Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

    Fraud Alert : Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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    Quality Engineer Ii • Billerica, MA, United States