8 AM to 5 PM OT not required – but may be requested as applicable
Encompasses the application of scientific and technological principles concerned with the integrity of manufactured products and processes from an engineering standpoint, esp. design specifications, testing procedures, and minimum quality standards.
Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Works closely with Engineering in designing and analyzing inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications.
Audits quality systems for deficiency identification and correction. Understanding of CAPA, Supplier Corrective Action, Nonconforming Material Reports (NCMR), Return to Vendor (RTV), Product Hold, Escalation and Release. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Thorough understanding of ISO 9001, ISO 13485, & ISO 17025. Areas of specialization include: design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
May be certified in lean and six-sigma quality engineering methodologies.
May also be responsible for the unit's Performance Excellence (Six-Sigma) project portfolio, assuring the effective use of different improvement methodologies (DMAIC, Lean, DESGN, etc) toward the achievement of division or plant strategic goals.
Assist with execution of validation
Product Identification and Control
Product measurement reporting and maintenance of Records
Assist with Sterility Testing program
Maintain Gage Calibrations
Complaint investigation support
Assist with Disposition of Lab Material
Excellent Communication Skills
Other duties as assigned
Considerable technical and content knowledge of the job.
Understands practical applications, able to solve complex problems, full mastery of regular situations encountered. Independently able to solve the vast majority of problems and ambiguities by examine pertinent facts and evidence.
Seeks direction for issues that cross functional areas and/or have broad impacts.
Works under limited site supervision. Coordinates other activities beyond routine tasks.
Recommends process improvements, meets or exceeds deadlines, and able to maintain confidentiality and ensure compliance.
Contacts outside of immediate work group are frequent and broad.
May or may not have external contacts. Contacts may be sensitive in nature.
Generate CAD Product Drawings
Maintain Lab Procedures
Maintain Good Documentation Practices
Internal Auditing Experience
Thorough understanding of ISO 9001, ISO 13485, & ISO 17025.