Within Quality you define and specify activities, processes, or standards to fulfill the quality requirements for services, materials, components, or products.
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Summary of the Role:
Inspectors will verify the product coming in and the product going out determining if they meet customer requirements.
Tasks and Responsibilities:
Education and Experience:
Competencies:
Travel:
Benefits include:
401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Application:
Last Application Date 5/17/2025
As an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.
This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. Green Card Holder), Political Asylee or Refugee.
The Quality Manager at TSS Bridgwater is crucial in leading the quality assurance team to ensure high-quality product delivery across various industries, including automotive, aerospace, food & beverage, and general manufacturing. This role involves overseeing product and process verification during
Summary of the Role:
Quality Engineers have the technical ability and expertise to solve complex problems. Problems can be either technical, with regards to product quality, or commercial, regarding processes. Both types of problems need specialized abilities to determine the root cause so that they can be resolved. Many quality functions, such as auditing or PPAP/FAIR need technical training and understanding of the applicable standards.
Tasks and Responsibilities:
Education and Experience:
Competencies:
Travel:
Application:
Last Application Date 5/10/2025
The final compensation offered to the candidate may be based on geographical location, work experience and/or skill level. Additions to the compensation packing, including but not limited to paid time off, insurance benefits and 401(k) eligibility, will be outlined at the time of the job offer.
Compensation range: $75,000-$95,000
401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
As an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.
This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. Green Card Holder), Political Asylee or Refugee.
The Quality Engineer is responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations.
Tasks and Responsibilities
Education and Experience
Required:
Desired:
Competencies
Summary
The primary role is the inspection of components to ensure compliance with specifications.
Tasks and Responsibilities
Education and Experience
Required
Desired
Competencies
Application
Last Application Date: 05/16/2025
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Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. Responsible to plan and coordinate quality assurance activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.
Responsbilities
Quality Engineer Expectations:
• In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy
• Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)
• Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ)
• Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product
• Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
• Perform measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
• Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
• Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects
• Initiate and perform root cause analysis, using statistical and capability analysis to solve problems
• Adhere to the company’s Quality System (QS), write, and approve QS documents
• Review and ensure compliance with QMS of all validation documents and records
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed
• Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)
• Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians
• Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA),
• Support internal and external audits
Senior Quality Engineer Expectations:
• Train company personnel as needed in areas such as the use of equipment, inspection methods, statistical methods, processes, and quality system.
• Serve as project team leader on projects. Schedule project activities and strive to meet deadlines
• Provide mentorship to other Quality Engineers and Technicians through experiences and education as opportunities arise
• Develop ideas and strategies to improve operational efficiency, add value, aid business performance, and work towards a culture of continuous improvement
• Successfully manage multiple projects simultaneously
• Drive best practices through the application of effective quality engineering principles and procedures across functions
As a valued Trelleborg team member, you will enjoy:
Qualifications:
Desired:
Senior level: including all the above
5+ years in a regulated manufacturing environment
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
Competencies
Ability to read, write, speak and understand the English language (with a translator, if necessary)
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office, Project, Access and JMP
• Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards
• Working knowledge of statistical methods associated with six sigma and quality control.
• Able to perform math functions
• Effective project leader
• Experience with lean manufacturing principles and their implementation
• Good hand/eye coordination and depth perception
• Good manual dexterity
• Correctable normal reading distance vision
Travel: Up to 25% across sites
Salary info:$78k and up based on experience.
Influencez le futur. Accélérez votre carrière avec Trelleborg et commencez à façonner l’Industrie depuis l’intérieur.
Qui sommes-nous ?
Trelleborg Industrial Solutions (TIS) est un leader mondial de solutions polymères innovantes pour l’industrie. TIS est l’une des trois Business Areas du Groupe Trelleborg, avec un total d’environ 6 000 employés dans le monde.
Fluid Handling Solutions (FHS) est une Business Unit de Trelleborg Industrial Solutions. Avec plus de 1.300 employés, Trelleborg FHS est un acteur clé offrant des solutions de haute performance : systèmes de sécurité pour le transfert de pétrole, tuyaux industriels, feuilles de caoutchouc, joints d’expansion et solutions anti-abrasives pour le secteur minier. Basée à Lyon - France, Trelleborg FHS dispose de sites de production en France, Turquie, Espagne, Royaume-Uni, Pays-Bas, République Tchèque et Australie.
Le Technicien Qualité et sécurité est en charge de garantir que les produits, processus et services respectent les normes de qualité, les réglementations en vigueur et les attentes des clients tout en assurant la sécurité des employés, des équipements et des installations. Il joue un rôle stratégique en pilotant des initiatives d’amélioration continue, en veillant à la conformité réglementaire et en promouvant une culture d'excellence et de prévention au sein de l’entreprise.
Conformité & Sécurité :
Opérationnel :
Stratégie :
Team Leadership:
Assurance Qualité :
Rapport et communication :
Engagement:
Education:
Compétences techniques
Compétences stratégiques
Interaction avec :
Poste local donc un minimum de déplacements est requis pour les réunions PA/BU (quelques jours/an).
Basé sur site à Lyon Dardilly, France.
Comment candidater ?
Trelleborg est un employeur promouvant l’égalité des chances. Nous célébrons la diversité et nous nous engageons à créer un environnement inclusif pour tous les employés. Nous veillerons à ce que les personnes handicapées bénéficient des mesures d’adaptation nécessaires leur permettant de candidater. Veuillez nous contacter pour toute demande particulière.
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