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What You Will Do: Lead and direct regulatory (e.g. FDA and ISO), internal and external (customer) audits within the company to ensure compliance to applicable regulatory and corporate standards / requirements are met. This includes developing and maintaining an audit schedule, performing internal audits, scheduling personnel to assist with audits, maintaining a list of qualified internal auditors, writing and issuing audit reports, and verifying corrective actions Manage a successful CAPA syst ...Read more about Senior Quality ManagerMore
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Spray coat medical implant devices in preparation for sintering heat treatment, using established procedures, to meet engineering and customer specifications. Hand-coat parts using the spatulation method as required. Inspect coated parts for acceptability with customer requirements. Perform other duties as directed by department Lead. What You’ll Do: Learn to review documentation (Job Travelers) to verify part identity, quantities, and coating (e.g. binder and bead mesh size) requirements. ...Read more about CoaterMore
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What You’ll Do: Operate various CNC machines independently Perform machine setup activities Independently perform daily machine preventative maintenance Process required documentation (job traveler, I.P. sheets etc.) Facilitate use of First Piece Log Conduct tool changes Conduct change-overs and tool size changes Set tooling on all machine types within assigned zone What You’ll Need: 5+ years of relevant experience operating a CNC machine Advanced print reading knowledge Advanced GD&T ...Read more about CNC Machinist IIIMore
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We are looking for a CNC Lathe Machinist to join our Avalign Integrated Medical Solutions team in Mentor, OH. The CNC Lathe Machinist operates conventional, special purposes, and numerical control (CNC) machines and machining centers to fabricate parts according to customer specification. What You'll Do: Independently perform daily machine preventative maintenance (P.M.’s) activities. Accurately and consistently document all performed tasks on appropriate records (First Piece Inspection log, w ...Read more about CNC Lathe MachinistMore
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We are looking for a Senior Manufacturing Engineer to join our Avalign Technologies Slice team in Akron, OH. The Manufacturing Engineer will design, improve, and build the manufacturing process for medical devices, products and systems according to customer requests by developing and testing specifications and methods. What You’ll Do: Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results Directly supports the operations team May be called ...Read more about Senior Manufacturing EngineerMore
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We are looking for a CNC Lathe Machinist to join our Avalign Integrated Medical Solutions team in Mentor, OH. The CNC Lathe Machinist operates conventional, special purposes, and numerical control (CNC) machines and machining centers to fabricate parts according to customer specification. What You'll Do: Independently perform daily machine preventative maintenance (P.M.’s) activities Accurately and consistently document all performed tasks on appropriate records (First Piece Inspection log, ...Read more about Lathe Machinist 1More
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