Quality Engineer
4 weeks ago
Responsibilities: Establish and maintain master validation program, including site and individual products and process master validations. Create/Review/Support validation protocols and reports to support process and reliability improvements. Support complaint handling program, including complaint analysis, investigation, and follow up. Lead and/or support reliability and process improvements projects from quality perspective Establish and maintain process controls/SPC for specific production processes. Support corrective and preventive action (CAPA) program Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements. Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety. Review and provide feedback of protocols and reports, test vendor qualification, and testing management. ssist with the development and maintenance of product risk management files. ssist with design verification testing and test method assessment and validation activities. Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods. Participate in failure investigations to analyse internal system or process failures and to implement corrective and preventive action. Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented. udit Design History Files and works with cross functional team to resolve documentation issues. Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools. Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products. Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective, and remediation action plans, and for corrective and preventive actions. Demonstrate the ability to implement ISO 14971, including risk evaluation techniques. Requirements: Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university 5+ years related experience and/or training; or equivalent combination of education and experience •Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military, nuclear. working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus. Familiarity with test methods and standards for the design, verification, and validation of medical device products is required. Experience with PPAP, PMEA
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Quality Engineer
4 days ago
North Haven, United States Futran Solutions Full timeJob Title : Quality Engineer location : North Haven, CT Qualification: • BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering • Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering. • Contribute to...
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Quality Engineer
3 weeks ago
North Haven, United States Futran Solutions Full timeJob Title : Quality Engineerlocation : North Haven, CTQualification:• BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering• Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.• Contribute to...
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Quality Engineer
3 weeks ago
North Haven, United States Futran Solutions Full timeJob Title : Quality Engineerlocation : North Haven, CTQualification:• BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering• Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.• Contribute to...
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Quality Engineer
6 days ago
North Haven, United States Futran Solutions Full timeJob Title : Quality Engineerlocation : North Haven, CTQualification:• BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering• Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.• Contribute to...
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Quality Engineer
3 weeks ago
North Haven, United States Futran Solutions Full timeJob Title : Quality Engineer location : North Haven, CT Qualification: BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering. Contribute to...
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Quality Engineer
7 days ago
North Haven, United States DBSI Services, Inc. Full timeJob Title: Quality Engineer Location: North Haven, CT (Onsite) Job Description: •Contribute to continuous improvements in overall product cost and quality. •Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. •Collaborate with Quality Engineering to provide manufacturing support....
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Quality Engineer
2 weeks ago
North Haven, United States O F Mossberg & Sons Inc Full timeJob Description Job Description Job purpose Under direction of the Director of Quality, perform a wide variety of duties to evaluate manufacturing processes to assess overall quality levels. Duties and responsibilities Assist in maintaining ISO 9001 QMS records, system, and document control. Perform/coordinate periodic ISO department audits Serve as ISO...
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Quality Engineer
3 weeks ago
North Haven, United States O.F. Mossberg & Sons Inc Full timeJob DescriptionJob DescriptionJob purposeUnder direction of the Director of Quality, perform a wide variety of duties to evaluate manufacturing processes to assess overall quality levels.Duties and responsibilitiesAssist in maintaining ISO 9001 QMS records, system, and document control.Perform/coordinate periodic ISO department auditsServe as ISO coordinator...
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Sr Quality Engineer
2 weeks ago
North Haven, United States Medtronic Full timeCareers that Change Lives In this exciting role as a Senior Post-Market Quality Engineer you will have responsibility for developing and implementing best practices in risk management and for providing risk management expertise throughout the product life cycle including development, market release, and post-market activities within the Robotics Surgical...
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Supplier Quality Engineer
6 days ago
North Haven, United States O.F. Mossberg & Sons Inc Full timeJob DescriptionJob DescriptionJob purposeUnder direction of the Director of Quality, the Supplier Quality Engineer plans and executes activities related to supplier evaluation, development, maintenance, and process improvement to drive quality excellence throughout the supply chain.Duties and responsibilities Maintain and improve the Supplier Quality...
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New Haven, United States The Chemical Engineer Full timeThis is what you will do: The Engineer II will join Injectable Drug Product Development group to support the development of Alexion’s bio-therapeutic candidates. Design and drive experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports. Join a dynamic and...
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Civil Engineer
1 week ago
North Haven, United States M&J Engineering Full timeOverview: M&J Engineering, P.C. is a quality provider of multi-discipline consulting services with over 300 employees. Since its inception in 2004, M&J has grown into diversified provider of engineering, construction management, construction inspection, technology, and environmental services to a broad range of clients, including federal, state and...
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Data Quality Engineer
1 week ago
New Haven, United States NR Consulting Full timeOverview The Data Quality Engineer is responsible for designing, developing, documenting, and performing data quality checks across all data assets. That includes ETL jobs, reports, dashboards, and data pipelines. The primary goal for this role is to ensure high quality of data delivered to internal stakeholders and customers. Validation of data in data...
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Quality Engineer
2 weeks ago
North Berwick, United States Quest Global Full timeJob DescriptionJob DescriptionQuality EngineerWork Location: North Berwick, Maine (Customer Site)Work Experience: Minimum 4+ years relevant to role and 4-year tech degree / 8+ years relevant to role with no / non-tech degree. Candidates with substantially more prior experience and responsibilities, may fit under a related progression roles - and are...
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Quality Engineer
7 days ago
North Berwick, United States QuEST Global Full timeJob Description Job Description Quality Engineer Work Location: North Berwick, Maine (Customer Site) Work Experience: Minimum 4+ years relevant to role and 4-year tech degree / 8+ years relevant to role with no / non-tech degree. Candidates with substantially more prior experience and responsibilities, may fit under a related progression roles - and are...
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Process Engineer
1 week ago
North Haven, United States Ulbrich Stainless Steels & Special Metals Full timeUlbrich Stainless Steels & Special Metals, Inc. is a high-precision, value added processor of stainless steels, special metals, and specialty wire products. Ulbrich was established in 1924 and is privately held. It has 9 wholly owned subsidiaries located in the US, Mexico, Canada, and Austria employ over 700 people worldwide. Our continued growth translates...
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Manufacturing Engineer
1 week ago
North Haven, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Perform equipment validation. Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Need to conduct qualification, verification, and validation activities to produce medical...
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Manufacturing Engineer II
1 week ago
North Haven, United States ATR International Full timeWe are seeking a Manufacturing Engineer II for a very important client Responsibilities may include the following and other duties may be assigned. •Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. •Design arrangement of machines within plant facilities...
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Experienced Quality Engineer
24 hours ago
North Charleston, United States The Boeing Company Full timeLeads integration of contractual and Boeing Quality Management System requirements into all aspects of proposals and program processes and documentation. Provides interpretation of complex requirements. Develops quality metrics, design and production Quality Engineer, Experience, Quality, Production Engineer, Engineer, Technology
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Manufacturing Quality Engineer
4 weeks ago
North Canton, United States CareerBuilder Full timeJob Description Job Description Company Overview: Paarlo Plastics Inc is a Custom Blow Molding leader dedicated to delivering superior products/services to our clients. We prioritize quality excellence and are currently seeking a talented Salaried Quality Engineer with a strong background in Excel to join our team. This position offers an exciting...