Quality Engineer - Combination Device - Wellesley MA/Hybrid

Wellesley Permanent USD80,000 - USD105,000
  • Manage all contract manufacturer connections for their Quality Team
  • Work under direct management to showcase your skills on a Hybrid basis

About Our Client

Our client is working on state-of-the-art cancer detection equipment designed to identify cancer during surgery. By working on both devices and ailments for cancer detection/treatment, they are working to simplify the process in which doctors use to treat cancer.

Job Description

The Quality Engineer will...

  • Manage supplier qualification and process validation activities at CMOs and critical suppliers related to clinical and drug product.
  • QA Reviewer and approver of Master Batch Records.
  • Lead supplier audits (standards in scope include PIC/S and ICH Q7A).
  • Manage requests for change and nonconformances identified with suppliers related to clinical and drug product.
  • Collaborate with the sustaining engineering and medical/clinical affairs team to investigate device issues related to Investigational Product used in clinical trials.
  • Perform quality release activities for all Investigational Product to support ongoing clinical trials.
  • Perform quality review on all clinical field service records and preventive maintenance.
  • Act as the quality representative on the device issues containment and adjudication meetings and assist the team in performing risk assessments.
  • Support equipment qualification process, including calibration and preventive maintenance for in house lab and field equipment to support clinical trials.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The Quality Engineer should have...

  • Experience in the biotechnology and/or pharmaceutical industry.
  • Experience in CMO operations.
  • Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment.
  • Thorough understanding of quality systems, cGMPs/cGCPs
  • Fluent with electronic Quality Management Systems (eQMS); Arena preferred
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices.
  • Certified Quality Auditor

What's on Offer

The Quality Engineer can expect...

  • Competitive Compensation and Benefits
  • Hybrid Work Model
  • High Level exposure to Upper Management
Cameron Cyker
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Job summary

Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Healthcare / Pharmaceutical
Contract Type
Consultant name
Cameron Cyker
Job Reference