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.
This is a remote, 4-month contract position. Candidate must be able to perform on-site evaluation/testing of returned complaint samples at the Wayne, PA facility up to one day per week.
location: Wayne, Pennsylvania
job type: Contract
salary: $70 - 75 per hour
work hours: 9 to 5
- 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
- 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.)
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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