Quality Engineer

Job Description

Job Description

MGS has an exciting opportunity for a Quality Engineer to join our MGS Richfield team.

As a Quality Engineer at MGS, you will be responsible for maintaining the Quality Management Systems ensuring product compliance to internal and customer specifications as well as compliance to MGS processes.

Additionally, you will be responsible for ensuring that new products meet all customer and MGS quality and documentation requirements when they are launched into production.

This is accomplished by developing and validating measurement systems, establishing in-process quality plans, validating production processes, submitting documentation for customer approval, and transferring knowledge.

Are you inspired by the ability to make a difference? Now is your chance to work as part of a new project development launch for a large, highly regarded healthcare customer on a program that that makes a difference to our team, our customers and their patients!

Below are additional duties and responsibilities :

• 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-9001 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.
• Assist in 2nd party, 3rd party, and internal audits.
• Assist in responses and corrective actions for audit findings.
• Approve product for shipment.
• 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.
• Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
• 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.
• Generate quality plans for new product launches
• Incorporate documented customer requirements
• Incorporate industry standard practices
• Incorporate MGS lessons learned
• 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 (FAT)
• 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
• Transfer knowledge to Operations through reviews and training
• Any other duties as assigned.

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.

About MGS

As a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations : robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner.

That's why we're the engineering and manufacturing partner of choice for today's leading Pharma, Diagnostic and MedTech innovators.

Serving customers from 12 strategically located facilities around the world, we transform our customers' most pressing challenges into innovations that improve lives.

To learn more about MGS, please visit www.mgsmfg.com.

A qualified Quality Engineer candidate would fulfill these requirements :

• High School Diploma or equivalent is required.
• BS degree in engineer or business is preferred.
• Three to five years of experience and / or training, or equivalent combination of education and experience.
• Demonstrated experience in problem solving.
• Demonstrated statistical analysis skills.
• GD&T experience.
• Experience in working with teams to achieve results.

MGS is an Equal Opportunity Employer.

Benefits :

To learn more about MGS Mfg. Group, go to www.mgsmfg.com. We offer a competitive benefits package including medical, dental and vision insurance, company paid life and disability insurance, paid time off, and a generous 401(k) match.