Quality Engineer

TriMas Corporation • Clinton Township, MI

1d • Onsite

About The Position

Acts as the primary advocate for compliance and Quality Assurance Engineering of medical devices and medical device components for the development of Validation programs and program compliance requirements such as Quality Plans, pFMEAs, and process control plans with the goal of 1) facilitating product safety and compliance, 2) of consistently meeting/exceeding customer’s expectations and 3) following and upholding TriMas Life Sciences principles thru-out the product life cycle.

Requirements

• A degree in a degree in engineering, life sciences, or a related field, along with knowledge of regulatory standards like ISO 13485, FDA 21 CFR Part 820.
• Strong communication skills: verbal, written and technical presentations.
• Working knowledge of statistics (e.g. Red X, Taguchi Methods, Disciplined Problem Solving, SPC Gage R & R) and production quality systems.
• Demonstrated ability to track improvement process through performance data.
• Strong organizational skills and the ability to successfully complete multiple tasks within established and changing deadlines.
• Excellent problem resolution skills.
• Working knowledge of Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Development of IQ/OQ and PQ protocols and summary reports
• Strong Risk Assessment support to 1) the client, 2) groups within the organization and 3) supplier-base
• Perform Risk Analysis in accordance with ISO-14971 and FMEA principles
• Quality Plans - layouts, sampling plan, and control dimensions for release per VoC-requirements
• Help the organization discern client pharma or device phase of development and assess device application
• Coordinate quality efforts with client for customer specific quality requirements
• Share best practices concerning the quality control of the product
• Facilitates Validation activities such client negotiations and technical writing of: Validation Plans, Validation Protocol Issue Resolution Reports- initiates appropriate corrective action, Validation Reports for submission to clients
• Support controlled quality runs for IQ, OQ and PQ activities
• Ensures all documentation is managed properly - forms are filled out and records properly stored
• Product is properly identified while updating - includes change management back thru client approvals
• Manages process changes to quality plan, metrology methods and other related documents
• Support the Corrective/Preventive action system through the identification, containment, investigation and resolution of NCRs.
• Participates and support third party and client site audits as needed
• Continually seeks out new ways to improve Omega Plastics quality processes to support our operations
• Other tasks as assigned by immediate supervisor and/or manager.

Benefits

• Medical Insurance and Prescription Drugs
• Dental Insurance
• Vision Insurance
• Flexible Spending Accounts
• Life Insurance
• Short-Term Disability
• Long-Term Disability Insurance (for eligible employees)
• Employee Assistance Plan (EAP)
• Paid Time Off (may include vacation and sick time)
• Retirement Program
• Other Voluntary Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level