JOB DESCRIPTION:

Shift: First Shift,Mon,Tue,Wed,Thu,Fri
MGS has an exciting opportunity for a Quality Engineer to join our MGS Richfield Manufacturing team.
The Quality Engineer ensures compliance with internal, customer, and MGS quality standards by maintaining the Quality Management System. The Quality Engineer supports product launches by developing measurement systems, creating in-process quality plans, validating production processes, preparing customer documentation, and transferring knowledge to the Richfield manufacturing facility.

REQUIREMENTS FOR MEDICAL PRODUCT FOCUS

• Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
• Understand 21 CFR Part 820 Quality System Regulation – Good Manufacturing Practice for the Medical Devices.
• Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.
• Understand medical customer-specific requirements.

EXPERIENCE AND SKILLS:

A qualified Quality Engineer candidate would fulfill these requirements:

• BS in Engineering, Quality, or related technical field is preferred.
• Three to five years of experience and/or training, or equivalent combination of education and experience.
• Understanding of quality standards and regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820.
• Experience with Microsoft Office products – Excel, Word, PowerPoint
• Demonstrated experience in problem solving.
• Demonstrated statistical analysis skills.
• Excellent interpersonal, communication, and presentation skills.
• GD&T experience is a plus.

Job Benefits:
We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.
From: MGS Mfg. Group, In

Address customer complaints and internal quality issues.

• Initiate the corrective action process and use the appropriate quality tools to ensure that the problem is satisfactorily resolved.
• Investigate issues and acquire input from subject matter experts.
• Interface with customers.
• Drive the team to implement permanent corrective actions.
• Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
• Record all actions on internal and customer-specific documentation, including updating customer portals.

Address suspect and non-conforming product.

• Initiate stop-ship and containment activities.
• Initiate RMA process for product in customer’s possession.
• Recommend disposition of product.
• Develop inspection/sort/rework instructions.
• Develop customer waiver (deviation) documentation and obtain customer approval, if required.

Maintain the Quality Management System (QMS).

• Understand ISO-13485 Quality management systems – Requirements.
• Ensure continuing compliance to both internal MGS processes as well as requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements. See below for additional requirements for automotive and medical products.
• Assist in 2nd party, 3rd party, and internal audits.
• Assist in responses and corrective actions for audit findings.

Approve product for shipment.
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- Perform batch record reviews.
- Generate Certificate of Analysis, as required.
- Release product in ERP system.

Support engineering change process.

• Interface with customer to ensure compliance to customer request and requirements.
• Manage product inspection and testing activities.
• Complete required documentation.
• Submit documents to customer and obtain customer approval.

Support Operations.

• Resolve inspection issues to allow product movement in a timely manner.
• Update production documents when errors are found.
• Train production and QC staff on customer requirements, inspection techniques, and rework instructions.

Support advanced product quality planning

• Participate in design review, process planning, and failure mode analysis
• Provide input on the selection of Key Product Characteristics
• Provide input on gaging methods and equipment

Generate quality plans for new product launches

• Incorporate documented customer requirements
• Incorporate industry standard practices
• Incorporate MGS lessons learned
• For medical customers, generate and get customer acceptance of an IQ/OQ/PQ protocol

Develop and validate measurement systems

• Interface with gage & equipment manufactures to ensure understanding of requirements
• Establish validation plans/protocols
• Ensure validation is completed and that all requirements are met
• Generate clear instructions for gage end-users
• Perform MSA studies and ensure that Gage R&R is acceptable
• Generate and document golden samples and/or challenge parts

Obtain customer approval

• Compile measurement and process performance data
• Assemble documentation package
• Review for completeness and accuracy
• Drive correction of all errors
• Submit to customer and drive for approval
• Release production documentation in the document control system