Senior Quality Engineer

Senior Quality EngineerLocation: Roseville, MN, US Work Arrangement: OnsiteWho We Are At CPC (Colder Products Company), we're not just connecting fluid lines – we're connecting people, ideas, and possibilities. For nearly 50 years, we've been engineering cutting-edge fluid connection technologies that power industries from biopharmaceutical, thermal management (liquid cooling of electronics), medical, industrial, and chemical handling markets. But what sets us apart? Our people. We're a team of problem-solvers, innovators, and forward-thinkers who thrive in a culture that values collaboration, creativity, and continuous improvement. Headquartered in Minneapolis/St. Paul, with over 700 employees in 14 countries, we're growing fast, and we want you to grow with us!Your RoleAre you ready to make an impact and work with a company that values your expertise, ideas, and career growth? As our next Senior Quality Engineer, you'll be at the forefront of shaping our organization's success. This isn't just a job – it's a career move where you'll thrive, learn, and enjoy coming to work.Responsibilities:Risk Management SME: Lead cross-functional meetings to ensure market needs, engineering spec and risk are aligned and mitigated or properly justified for leadership approval and identify process risks for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).Provide feedback on new tests or test methods to resolve measurement discrepancies and ensure correlation in measurement method between in-process, Receiving Inspection and Risk Management in compliance with CPC requirements.For example, if a new test is required to mitigate a risk identified in Risk Management the NPI QE needs to be involved in the development and approval of that new test method.Attend team meetings and provides Quality Engineering input for potential design, process, and project risks.Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.Support Design/Service Transfer by providing input to design and manufacturing, Project Management and Supply Chain including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that new and refurbished tools and associated processes result in products that can be adequately manufactured and tested.Review and develop design control documentation for accuracy, completeness and user-friendly content that meets the needs of target audience in support of device history records and device master records.Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ).Collaborate cross-functionally as NPI Quality Engineer; a Core Team Member, on new product/service development teams to ensure conformance with CPC QMS and lead deviation justification if necessary.Provides Statistical recommendations for formal DVT and Characterization testing as well as for process and other informal testing.Collaborate with suppliers and applicable CPC functional teams in developing statistically valid, highly capable, repeatable, and reproducible test methods for formal DVT, Characterization and other informal testing.Develop validation plans and protocols to verify that components and supplier product meets requirements.Review and approve DVT test protocols.Provide data driven feedback on results.Review and approve process verification/validation test plans, protocols, reports, inspection procedures and associated documentation.Provide data driven feedback on results to resolve measurement discrepancies and ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.Ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.Problem Solving and Root Cause Analysis SME; Lead cross-functional meetings to investigate design-related issues (DVT failures), Facilitate, and conduct root cause analysis, Facilitate implementation and effectiveness of corrective and preventive actions (CAPA). Ensure traceability between design inputs, outputs, and test results. Performs other job duties as assigned to meet business needs.QualificationsBasic Requirements: Bachelor's Degree in Engineering required. 10+ years of experience in Quality, Manufacturing, or related field. Proficient with Quality System Regulations and ISO Quality System Standards. Strong understanding of ISO 13485 and ISO 9001. Excellent analytical decision making and problem-solving skills. Proven ability to resolve issues and participate in process improvement activities. Ability to define problems, collect data, establish facts and draw conclusions. Superb written communication skills, with a keen eye for detail and focused on target audience. Ability to effectively present information in one-on-one and small group situations. This role may require less than 10% of travel, domestically. Candidates should be comfortable with occasional travel as needed to support business objectives.Why You'll Love Working HereOur Culture At CPC, our people aren't just employees, they're the driving force behind our success. We've built a culture rooted in respect, collaboration, and integrity, where every voice matters, and innovation thrives. It's not just us saying it; CPC has been recognized as a Top Workplace 6x in the past 7 years, because we genuinely care about our employees' growth, well-being, and success. This isn't just a workplace; it's a community where you'll feel valued, empowered, and inspired to do your best work every day.Growth & Development We invest in you . Whether you're looking to expand your skills, take on new challenges, or advance your career, we're here to support you. We offer:Mentorship, hands-on training, and career development opportunities to help you reach your full potential.Tuition Assistance to support continued education, plus scholarship programs for children of eligible employees.A Co-Op and intern program in partnership with several universities for hands-on industry experience.Recognition programs that celebrate your contributions, from employee loyalty awards to peer-to-peer recognition.Because when you succeed, we all succeed.Work/Life Balance We get it – work is important, but so is life outside of it. That's why CPC ensures you have the time and flexibility to live, recharge, and give back. Our programs include:Multiple paid-time off programs, including vacation, sick time, company-paid holidays, bereavement leave and paid volunteer time to support causes you care about.Paid Parental Leave so you can focus on what matters most.Wellness support, including access to in-person and online advisors for mental, financial, and overall well-being.We believe that a balanced, fulfilled team creates the best workplace.Benefits & Compensation At CPC, we offer a comprehensive benefits package designed to support your health, financial security, and overall well-being, including but not limited to:Health & Wellness: Comprehensive Medical, Dental, Vision coverage starting day one for you and your family. Health Savings Account (HSA) contributions for eligible plans. Company-paid Long-Term & Short-Term Disability and Life Insurance for added security. Onsite gym & wellness programs to help stay active and healthy.Financial Benefits: 401k plan with automatic employer contributions starting on day one, plus profit-sharing to invest in your future. Referral bonuses – get rewarded for connecting talented friends and family to CPC job openings.Pay Range: $105,000.00 - $120,000.00 / annual This range is the pay scale for this role in Minnesota. Individual compensation is based on skills, experience, and qualifications related to this position.Bonus Eligibility: YesJoin Us If you're ready to be part of an innovative team that values connection and collaboration, we want to hear from you! We consider several job-related, non-discriminatory factors when determining the pay rate for a position, including, but not limited to, the position's responsibilities, a candidate's work experience, a candidate's education/training, the position's location, and the key skills needed for the position. Pay is one of the Total Rewards that we provide to compensate and recognize employees for their work.Benefits: Benefits for this position include: Our total rewards package of eligible team members also includes: a 401(k) savings plan with employer contributions; medical, dental and vision insurance; wellness programs; health savings account, health care and dependent care flexible spending accounts; company paid short-term disability and long-term disability; company paid employee basic life