Lincotek Medical
Overview
The Quality Engineer is responsible for bringing new products and processes to market on time and within budget, with a strong focus on process qualification, product quality, packaging validation, and continuous improvement. This role works cross-functionally with engineering, operations, and external partners to ensure compliance with regulatory, customer, and internal requirements, while fostering a culture of quality and accountability. Responsibilities
Lead and support process qualifications and validations, including packaging validation (protocol development, execution, data analysis, and reporting) per ISO 11607, ISO 13485, and customer requirements. Act as lead quality reference for internal and external customers regarding additive manufacturing, coatings, packaging, and assembly applications. Read, analyze, and interpret customer and regulatory specifications; manage qualification kickoff meetings and drive actions to closure. Develop, revise, and maintain quality procedures, inspection plans, control plans, FMEAs, and work instructions. Establish and maintain effective document control practices in support of product assurance and regulatory compliance. Implement inspection and test methods, including sampling plans and acceptance criteria, ensuring alignment with industry standards. Lead root cause analysis and corrective/preventive actions (8D, 5 Whys) to permanently eliminate nonconformities. Support internal and supplier audits to verify compliance with Quality Management System (ISO 13485, FDA 21 CFR Part 820) and customer requirements. Monitor and analyze key metrics (Quality, Rework, Scrap Cost) and implement continuous improvement initiatives using Lean and Six Sigma tools. Provide training to production and quality personnel on quality procedures, inspection techniques, and regulatory awareness. Support vendor qualification and material approval activities by coordinating with suppliers to resolve quality issues and ensure compliance with specifications. Participate in customer and notified-body audits. Qualifications
Bachelor's degree in Engineering, Material Science, or related technical field. Minimum 3–5 years of experience in a regulated manufacturing environment (medical device, aerospace, or equivalent). Proven experience in process validation (IQ/OQ/PQ) and use of risk management tools (FMEA, Control Plan). Understanding of ISO 13485 and 21 CFR 820 Quality System Regulations. Ability and willingness to take ownership of packaging validation and sterile barrier qualification activities, learning and applying ISO 11607 principles through hands-on project execution and cross-functional collaboration. Hands-on experience with inspection methods, sampling plans, and acceptance criteria development. Strong analytical and problem-solving skills using root cause analysis tools (8D, 5-Why, Fishbone). Excellent written and verbal communication skills, including the ability to interface effectively with customers, auditors, and cross-functional teams. Proficiency in Microsoft Office and familiarity with ERP systems (SAP, Oracle, or equivalent). Preferred:
Master’s degree in Engineering, Quality, or related discipline. Preferred:
Exposure to medical device packaging, clean-room assembly, or sterilization validation processes. Preferred:
Certification or practical experience in Lean Six Sigma (Green Belt or higher). Preferred:
Working knowledge of Minitab or other statistical analysis tools (SPC, capability studies, GR&R). Preferred:
Experience with supplier audits, NPI/APQP, or customer qualification activities. Preferred:
Ability to read and interpret engineering drawings, GD&T, and use precision measurement tools. Lincotek Medical provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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The Quality Engineer is responsible for bringing new products and processes to market on time and within budget, with a strong focus on process qualification, product quality, packaging validation, and continuous improvement. This role works cross-functionally with engineering, operations, and external partners to ensure compliance with regulatory, customer, and internal requirements, while fostering a culture of quality and accountability. Responsibilities
Lead and support process qualifications and validations, including packaging validation (protocol development, execution, data analysis, and reporting) per ISO 11607, ISO 13485, and customer requirements. Act as lead quality reference for internal and external customers regarding additive manufacturing, coatings, packaging, and assembly applications. Read, analyze, and interpret customer and regulatory specifications; manage qualification kickoff meetings and drive actions to closure. Develop, revise, and maintain quality procedures, inspection plans, control plans, FMEAs, and work instructions. Establish and maintain effective document control practices in support of product assurance and regulatory compliance. Implement inspection and test methods, including sampling plans and acceptance criteria, ensuring alignment with industry standards. Lead root cause analysis and corrective/preventive actions (8D, 5 Whys) to permanently eliminate nonconformities. Support internal and supplier audits to verify compliance with Quality Management System (ISO 13485, FDA 21 CFR Part 820) and customer requirements. Monitor and analyze key metrics (Quality, Rework, Scrap Cost) and implement continuous improvement initiatives using Lean and Six Sigma tools. Provide training to production and quality personnel on quality procedures, inspection techniques, and regulatory awareness. Support vendor qualification and material approval activities by coordinating with suppliers to resolve quality issues and ensure compliance with specifications. Participate in customer and notified-body audits. Qualifications
Bachelor's degree in Engineering, Material Science, or related technical field. Minimum 3–5 years of experience in a regulated manufacturing environment (medical device, aerospace, or equivalent). Proven experience in process validation (IQ/OQ/PQ) and use of risk management tools (FMEA, Control Plan). Understanding of ISO 13485 and 21 CFR 820 Quality System Regulations. Ability and willingness to take ownership of packaging validation and sterile barrier qualification activities, learning and applying ISO 11607 principles through hands-on project execution and cross-functional collaboration. Hands-on experience with inspection methods, sampling plans, and acceptance criteria development. Strong analytical and problem-solving skills using root cause analysis tools (8D, 5-Why, Fishbone). Excellent written and verbal communication skills, including the ability to interface effectively with customers, auditors, and cross-functional teams. Proficiency in Microsoft Office and familiarity with ERP systems (SAP, Oracle, or equivalent). Preferred:
Master’s degree in Engineering, Quality, or related discipline. Preferred:
Exposure to medical device packaging, clean-room assembly, or sterilization validation processes. Preferred:
Certification or practical experience in Lean Six Sigma (Green Belt or higher). Preferred:
Working knowledge of Minitab or other statistical analysis tools (SPC, capability studies, GR&R). Preferred:
Experience with supplier audits, NPI/APQP, or customer qualification activities. Preferred:
Ability to read and interpret engineering drawings, GD&T, and use precision measurement tools. Lincotek Medical provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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