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Quality Engineer

Randstad Life Sciences
Wayne, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

4 months (potential for extension) 

Part-time - 20 hours/week

Mostly remote.  This resource will be expected on-site in Wayne, PA up to one day per week to perform on-site evaluation/testing of returned samples (potentially once every 2 weeks).  Right now this function happens on Tuesday each week.  They would like to maintain that schedule if possible.  All other work can be performed remotely.

- Need candidates with strong design control experience.  Must come from the medical device.

Job Summary:

The Quality Engineer will gather information and prepare documentation to compile Design History Files and Risk Management Files for combination products in accordance with FDA 21 CFR Part 4, 820, ISO 13485, ISO 14971, and ICH Q9. The role will ensure Design Control/Risk procedures meet GMP requirements and will lead revisions to procedures when necessary.

The Quality Engineer will review Product Quality Complaint investigations for completeness, accuracy, and compliance with GMP and internal procedures. The role will also support investigations of Product Quality Complaints through on-site evaluation/testing of returned samples.

Essential Responsibilities:

Assess existing Design History File and Risk Management file to identify gaps or areas for improvement
Collaborate with internal functions (Pharmaceutical Sciences, Supply Chain, Pharmacovigilance) and contract manufacturers to gather and/or create deliverables for Design History Files and Risk Management Files
Revise SOPs governing combination product processes such as Design Control, Risk Management, Device Usability as necessary
Revise and establish procedures to comply with global GMP requirements for introduction of device/combination products to ex-US regions
Prepare change control documentation to assess the impact of changes on existing Design History Files and Risk Management Files
Review and approve Product Quality Complaint (PQC) investigations in electronic management system (Veeva)
Evaluate and test returned Product Quality Complaint samples
Identify and escalate compliance issues to Senior Management

Experience and Qualifications:

Bachelor of Science degree
5 + years of relevant GMP experience
Solid understanding of US and international regulatory requirements and guidelines for Design Control and Risk Management
Experience preferred in execution of key elements of Design Control (design reviews, design verification, management of design history file) and Risk Analysis processes (design, process and use FMEAs.)

Randstad Life Sciences

Why Work Here?
Randstad Life Sciences is a leader in the industry with connections to market-leading clients in the biotech, medical, & pharma industries.


Wayne, PA
19087 USA



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