Quality Engineer

Quality Engineer

Company:
Omega Plastics Inc

Primary

Location:

24401 Capital Blvd, Clinton Township, MI 48036 USA

Workplace Type:
On-site

Employment Type:

Salaried | Full-Time

Function:
Quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Position Summary:

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 planswith the goal of
1) facilitating product safety and compliance,
2) of consistently meeting/exceeding customer’s expectations and
3) following and upholding Tri Mas Life Sciences principles thru-out the product life cycle.

• 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

• Validation protocol approval
• Completion and approval of risk assessments support NCRs, CCRs and SCCs
• Performance of internal audits and citing nonconformances

• Uphold and communicate the purpose, principles, and vision of Tri Mas Life Sciences
• 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
• 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
• Access FDA pharma and medical device web site for up-to-date requirements
• Coordinate quality efforts with client for customer specific quality requirements
• Share best practices concerning the quality control of the product
• Performance of internal audits which includes performing assessments for compliance to 21 CFR 820 and ISO 13485:2016 standards

• 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.

Tri Mas Life Sciences is a global provider of precision injection-molded components and assemblies for the medical device, diagnostic, pharmaceutical and surgical markets. The company serves key industries, including medical, packaging, industrial and consumer goods, and through our trusted brands, we deliver innovative, high-quality solutions that support our customers from prototype to full-scale production.

Our work enables life-saving technologies and products that improve people’s lives, and we take pride in being part of that purpose every day.

At Tri Mas Life Sciences, we believe our success begins with our people. We are committed to creating an environment where every employee feels valued, supported and inspired to contribute their best work.

When you join our team, you become part of a…