Quality Engineer

Koch Business Solutions, LP
life insurance, parental leave
United States, Massachusetts, Clinton
1 Union Street (Show on map)
Mar 24, 2025
Your Job Our Clinton, MA location is seeking a Quality Engineer to support manufacturing of injection molded parts and assembly. Successful candidates will have strong communication skills to collaborate with internal and external teams as well as problem-solving and analytical skills. This role offers a $5,000 sign-on bonus Our Team Phillips-Medisize is a Medical Device Manufacturer that works with Plastic Injection Molding of the parts. The Quality team has four team members and the supervisor. They are very supportive group of both internal and external customers who enjoy learning and sharing knowledge with each other. This role has a variety of tasks that offer new challenges and growing opportunities. What You Will Do * Responsible for QMS deliverables, including but not limited to: customer complaints, risk analysis, failure mode and effects analysis, CAPA, and process/equipment verification/validation * Utilize quality tools such as process flowcharting, Pareto analysis, correlation and regression analysis, Design of Experiments (DOE), Gage Repeatability and Reproducibility (Gage R&R), Statistical Process Control (SPC), and trend analysis to address manufacturing quality issues. * Create and implement required Verification and Validation plans, and develop and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) for equipment, injection molding, and assembly processes. * Communicate and coordinate validation activities and approvals, both internally and externally. * Initiate and review change management requests and deviations. * Complete the Production Part Approval Process (PPAP) as per the customer requirements. * Collaborate with engineering, operations, customers, and vendors to meet all quality requirements. * Assist with customer and third-party quality audits and represent quality in Advanced Quality planning (AQP) meetings. * Review and approve engineering drawings and manufacturing instructions. * Author and update work instructions and documents to ensure compliance with ISO 13485:2016 and current Good Manufacturing Practices (cGMP). * Report product/process performance metrics to management quarterly and support Lean Six Sigma initiatives. * Acknowledge and adhere to quality agreements and standards set by each customer. * Develop and implement statistical incoming and in-process sampling/control plans. * Serve as a communication liaison between customers and the manufacturing facility. Who You Are (Basic Qualifications) * Four (4) years or more Quality Engineering experience in a regulated industry * Bachelor's degree in engineering or science * Experience in quality management systems, CAPA, and validation processes * Experience using Minitab * Experience with ISO 13485:2016 * Experience with SAP or other ERP system What Will Put You Ahead * Experience with the injection molding process or injection molded parts * Experience with ISO 14971 and FDA regulations * Master's degree in engineering or science * Experience with SAP ERP with Quality Management Modules * Experience with Design of Experiments (DOE), Production Part Approval Process (PPAP), and Product/Process Validations * Certification in Lean Six Sigma, and/or Certified Quality Engineer (CQE) from the American Society of Quality (ASQ) * Certification as an ISO 13485:2016 Lead Auditor or Internal Auditor At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Hiring Philosophy All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy [1] here. Who We Are Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world's largest privately held companies. Discover your potential to make a difference. At Koch, employees are empowered to do what they do best to make life better. Learn how our [2] business philosophy helps employees unleash their potential while creating value for themselves and the company. Our Benefits Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results. Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click [3] here for additional information. (For Illinois E-Verify information click [4] here, [5] aqui, or [6] tu). #LI-JN2 References Visible links 1. https://jobs.kochcareers.com/pages/culture 2. https://www.kochind.com/about/business-philosophy 3. https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf 4. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_English.pdf 5. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_Spanish.pdf 6. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_Polish.pdf