EPM Scientific are looking for a number of Quality Engineers to join the Quality team. The Quality Specialists in question will provide hands-on support to ensure the duties and responsibilities are completed. Duties and requirements are listed below!
Job title and Description of Role: Quality Engineer
Anticipated Start Date: ASAP
Location: Remote(Pennsylvania)
Initial Length of Contract Assignment: 6-12 month minimum
Responsibilities:
- Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
- Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
- Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
- Regulatory requests including certification of compliance and product inquiries.
- Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
- Change Control - lead documentation change orders per quality system requirements.
- Validation/Qualification - Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
- Deviations – including risk assessment, closure criteria
- Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis.
Skills and Knowledge:
- Bachelor’s Degree
- Minimum of 2 years of experience in Quality Assurance with complaint processing role.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Must demonstrate the ability to investigate complaints with minimal guidance.
- Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
- Understand basic principles of good technical writing skills
- Background with firmware/hardware related complaints investigation a plus
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Demonstrated experience with MS Word, Excel, Adobe Acrobat and other commonly used software systems
- Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
- Must be able to work under minimum supervision and in a team environment.
- Must be a positive and energetic team player