Quality Assurance Specialist
4 weeks ago
About the Role:
MGS Mfg. Group is seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will be responsible for maintaining the Quality Management Systems, ensuring product compliance to internal and customer specifications, and ensuring that new products meet all customer and MGS quality and documentation requirements.
Key Responsibilities:
- Maintain the Quality Management System (QMS) and ensure continuing compliance to both internal MGS processes and requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements.
- 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, and drive the team to implement permanent corrective actions.
- Update production documents, including control plans, PFMEA, visual inspection criteria, incoming inspection plans, and in-process inspection reports.
- 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, and initiate RMA process for product in customer's possession.
- Recommend disposition of product, develop inspection/sort/rework instructions, and develop customer waiver (deviation) documentation and obtain customer approval, if required.
- Maintain the Quality Management System (QMS) and ensure continuing compliance to both internal MGS processes and requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements.
- Understand ISO-9001 Quality management systems - Requirements and ensure continuing compliance to both internal MGS processes and 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, and approve product for shipment.
- Perform batch record reviews, generate Certificate of Analysis, as required, release product in ERP system, support engineering change process, and interface with customer to ensure compliance to customer request and requirements.
- Manage product inspection and testing activities, update production documents, complete required documentation, submit documents to customer and obtain customer approval, and 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, and 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), and 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, and release production documentation in the document control system.
- Transfer knowledge to Operations through reviews and training, and any other duties as assigned.
- 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, and understand medical customer-specific requirements.
About MGS:
MGS Mfg. Group is a global provider of healthcare manufacturing solutions. We provide 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.
We are 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 our website.
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.
Benefits:
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.
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