Quality Engineer

$78.70K - $101.60K/yr

Other

Posted 6 days ago


Job description

Job Description:
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a minimum of five years of relevant experience and can quickly add value from day one.

Responsibilities:

  • Heavy focus on CAPA (Corrective & Preventive Action) execution.
  • Own CAPA records from investigation through closure.
  • Perform root cause analysis, issue assessment, and quality problem-solving.
  • Manage a portfolio of CAPAs end-to-end.
  • Partner with CAPA owners / cross-functional teams.
  • Conduct investigations + drive closure activities.
  • Review data sources and ensure thorough documentation/compliance.

Must-Have Skillset:

  • Strong CAPA background (non-negotiable).
  • ISO 13485 experience (medical device/regulatory environment).
  • Technical/STEM background.
  • Proven communication skills (highly emphasized due to fast-paced environment).
  • Ability to work independently and hit the ground running .

Nice-to-Have:

  • Project management experience (tracking, prioritization, coordination).

Traits for Success:

  • Strong communication + stakeholder management (critical).
  • Ability to handle multiple CAPAs simultaneously.
  • Detail-oriented with strong quality systems mindset.

Qualifications:
Must have Engineering degree- Technical experience and STEM related background.


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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Quality Engineer?

A: To succeed as a Quality Engineer, key technical skills include proficiency in statistical process control, Six Sigma methodologies, and proficiency in quality management software such as Minitab or QMS. Soft skills like effective communication, problem-solving, and analytical thinking are also crucial, as Quality Engineers must collaborate with cross-functional teams and identify root causes of defects. By combining these technical and soft skills, Quality Engineers can drive process improvements, reduce defects, and contribute to the overall success of their organization, ultimately supporting their career growth and effectiveness in the role.

Q: What is the career path for a Quality Engineer?

A: A Quality Engineer's career path typically begins with entry-level roles such as Quality Engineer Assistant or Junior Quality Engineer, where they develop foundational knowledge in quality management systems, statistical process control, and regulatory compliance. As they gain experience, they progress to mid-level roles like Quality Engineer or Senior Quality Engineer, where they take on leadership responsibilities, develop and implement quality improvement initiatives, and mentor junior team members. Senior Quality Engineers can then move into senior leadership positions, such as Quality Manager or Director of Quality, or transition into related fields like Six Sigma Black Belt or Operations Management, leveraging their expertise in quality assurance and process optimization.



Katalyst Healthcares & Life Sciences job posting for a Quality Engineer in Cambridge, MA with a salary of $78,700 to $101,600 Annually with a map of Cambridge location.