Sr. Supplier Quality Engineer

1 week ago

Bloomington, United States Quality Tech Services, LLC Full time

Overview About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com. Responsibilities Sr. Supplier Quality Engineer Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Supplier Quality Engineer will be responsible for overseeing and ensuring the quality of materials and services provided by suppliers to support sustaining and new product manufacturing. This will be completed through proactive supplier management, including supplier evaluations, audits, and performance monitoring ensuring compliance with company and customer standards, material requirements, and applicable regulations, which includes identifying and resolving quality issues, managing supplier change requests, and driving continuous improvement initiatives through supplier coaching and collaboration. This position will be responsible for the definition, implementation, and improvement of supplier-related practices and procedures. The position will provide technical guidance for measurement methodologies, material qualification, validation, and problem solving. Sr. Supplier Quality Engineer Job Summary Quality Engineering lead for materials and services provided by suppliers from new product introduction through sustaining. Lead and manage supplier corrective action and supplier change notification processes. Ensure compliance of supplier controls processes and agreements to applicable requirements of customers, ISO13485, FDA, and other regulations and standards as applicable. Provide leadership and supplier interface support for supplier quality issues through supplier quality system audits, supplier corrective action requests, supplier change requests, and technical discussions. Lead quality investigations using failure analysis, corrective and preventative actions, and trend analysis for customer complaints and manufacturing issues for materials and services provided by suppliers. Support identification of new suppliers and onboarding of suppliers through evaluation of capabilities and onboarding audits. Define supplier performance metrics, and proactively assess and report on supplier performance and capabilities through audits, meetings/business reviews, and performance monitoring. Manage the supplier audit process, including acting as lead auditor for supplier and internal audits to assess compliance with regulatory standards and company requirements, including developing an audit plan, executing audit, evaluation, follow-up, and resolution of audit observations and findings, and completing required documentation. Continually improve supplier performance through coaching, training, consequence enforcement, supplier motivation, and supplier roadmaps. Support inspection requirements and material qualification to ensure compliance with relevant requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents such as control and inspection plans. Understand and support validation of processes, equipment, and metrology, including creating protocols, analyzing data, and executing reports. Qualifications Sr. Supplier Quality Engineer Skills and Experience Bachelor's Degree: Mechanical, Industrial, or other Engineering or Physical science 7 years of experience with demonstrated ability in engineering, quality engineering, or quality control in a manufacturing setting. Knowledge of quality systems, regulatory requirements, and industry standards Process validation and material qualification. Regulated industry experience (ISO13485 preferred) Excellent problem solving and root cause analysis skills. Ability to read an interpret documents such as technical drawings, specifications, requirements, standards, and procedure manuals, including Blueprint reading and GD&T. Ability to make decisions using sound judgment while complying with policies, procedures, and applicable standards and regulations. Strong, clear, and effective communication and interpersonal skills. Statistical expertise with DOE, Capability Studies, and advanced statistical analysis methods, including statistical software (ex. Minitab) Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) Attention to detail and organizational skills. Ability to work in a fast-paced team environment, multitask, and prioritize. Ability to travel up to 20% to visit suppliers. Desirable Criteria & Qualifications Medical device experience. Experience working with suppliers. Project Management and leadership skills. Understand operating principles of inspection equipment. Lean Six Sigma Black or Green Belt training/experience/certification. Experience with managing and coaching of suppliers. Continuing Education; including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: "I would describe my coworkers as kind and friendly." ```{=html} ``` - "... I interned at QTS, then I went back to school... I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good, fun ride so far and I can't wait to keep it going" ```{=html} ``` - "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun" We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. QTS Benefits: As a Cretex Medical company, QTS offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. You are also automatically enrolled in Cretex's 401(k) retirement plan and the Cretex Profit Sharing Retirement Plan and are eligible for paid time off and short-term disability and long-term disability insurance. QTS also offers company specific benefits, such as: Free Parking Employee Appreciation Events Volunteer Opportunities Training and Development opportunities Tuition Reimbursement Annual Flu Vaccination Clinics Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

  • Quality Assurance Engineer

    4 days ago

    Bloomington, United States Quality Tech Services, LLC Full time

    Job SummaryWe are seeking a highly skilled Sr. Supplier Quality Engineer to join our team at Quality Tech Services, LLC. This is a full-time position responsible for overseeing and ensuring the quality of materials and services provided by suppliers to support sustaining and new product manufacturing.About the RoleThe ideal candidate will have 7 years of...

  • Supplier Management Lead

    4 days ago

    Bloomington, United States Quality Tech Services, LLC Full time

    About the PositionWe are seeking a highly skilled Sr. Supplier Quality Engineer to join our team at Quality Tech Services, LLC. This is a full-time position responsible for overseeing and ensuring the quality of materials and services provided by suppliers to support sustaining and new product manufacturing.About the CompanyQuality Tech Services, LLC is a...

  • Lead Supplier Quality Engineer

    1 month ago

    Bloomington, United States Onto Innovation Full time

    Onto Innovation is a leader in process control, combining global scale with an expanded portfolio of leading-edge technologies that include: 3D metrology spanning the chip from nanometer-scale transistors to micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for...

  • Supplier Quality Engineer Internship

    3 weeks ago

    Bloomington, United States Cook Group Full time

    Overview This position is a 12-week paid internship located in Bloomington, Spencer, or Ellettsville Indiana. It is offered for a period extending from mid-May through mid-August (exact dates depend on school calendars.) This position includes 401(k) options, an assigned mentor, capstone presentation, and intern events. If working onsite, you will also have...

  • Materials Compliance Specialist

    4 days ago

    Bloomington, United States Quality Tech Services, LLC Full time

    About the JobThis is a critical role in ensuring the quality of materials and services provided by suppliers to support sustaining and new product manufacturing. The Sr. Supplier Quality Engineer will be responsible for overseeing and ensuring the quality of materials and services provided by suppliers. The ideal candidate will have 7 years of experience in...

  • Supplier Quality Management Specialist

    3 weeks ago

    Bloomington, United States Onto Innovation Full time

    About the RoleThis is an exciting opportunity to join Onto Innovation's quality team as a Global Quality Assurance Lead. In this role, you will be responsible for overseeing supplier quality, developing and implementing quality management strategies, and driving continuous improvement initiatives.We are looking for a highly skilled and experienced...

  • Supplier Development and Quality Management Professional

    3 days ago

    Bloomington, United States Trigo ADR Americas Full time

    About the RoleThis is a unique opportunity to join TRIGO ADR Americas as a Aerospace Production Supervisor-Supplier Development Specialist. As a key member of our team, you will serve as a vital link between Prime Aerospace customers and their supplier base, leveraging your expertise in supply chain management to drive systemic changes that enhance supplier...

  • Manufacturing Operations and Supplier Development Manager

    8 hours ago

    Bloomington, United States Trigo ADR Americas Full time

    As an Aerospace Production Supervisor at Trigo ADR Americas, you will play a critical role in ensuring the success of our customers by managing supplier delivery performance and quality assurance.Key ResponsibilitiesSupplier Relationship Management: Build and maintain strong relationships with suppliers to ensure seamless delivery of high-quality...

  • Post Market Quality Engineer

    3 weeks ago

    Bloomington, United States Saluda Medical Full time

    Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord's response to stimulation and make real-time adjustments to therapy. Saluda is a global company with headquarters in Australia and offices in the United States and Europe. The Post-Market Quality Engineer is responsible...

  • Quality Assurance Professional

    4 days ago

    Bloomington, United States The Toro Company Full time

    Job DescriptionThe Advanced Quality Engineering Intern will partner with the Advanced Quality Engineering Team located at our worldwide headquarters. This position will support product development teams, suppliers, & manufacturing plants on new and existing products.This role requires collaboration with Engineering, Quality & Manufacturing teams to develop...

  • Post Market Quality Control Engineer

    4 days ago

    Bloomington, United States Saluda Medical Full time

    About Saluda Medical: We are a global company with headquarters in Australia and offices in the United States and Europe. Our flagship product is a closed-loop Spinal Cord Stimulation (SCS) therapy that can measure the spinal cord's response to stimulation and make real-time adjustments to therapy.Job Description:We are looking for a Post Market Quality...

  • Sr Manager, Warehouse

    2 months ago

    Bloomington, United States Proclinical Staffing Full time

    Sr Manager, Warehouse - Contract - Bloomington, IN Proclinical is seeking a Sr Manager, Warehouse for a contract role in Bloomington, IN. This role focuses on driving the creation and revision of policies and procedures to ensure world-class delivery to customers, both internal and external. Primary Responsibilities:The successful candidate requires a...

  • Software Test Practice Lead

    5 months ago

    Bloomington, United States COUNTRY Financial Full time

    COUNTRY Financial is seeking a highly motivated Software Test Automation Practice Lead/Sr. SDET (Software Development Engineer in Test)  for the TCoE team. This position is a senior role that offers an excellent opportunity for the ideal candidate to own and deliver the direction and strategy of Quality Assurance and Quality Engineering (QA/QE) practices...

  • Sr Engineer

    6 days ago

    Bloomington, United States Donaldson Full time

    Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make...

  • Quality Assurance Specialist

    10 hours ago

    Bloomington, Indiana, United States Cypress HCM Full time

    Cypress HCM is a leading manufacturer and supplier of medical devices headquartered in Monroe, WA.Job OverviewThis exciting role will work with the quality assurance, quality control, and operations team to ensure that products are manufactured safely with the highest level of quality promptly that meets or exceeds customer and regulatory...

  • Advanced Quality Engineering Intern

    5 days ago

    Bloomington, United States The Toro Company Full time

    Who Are We? The Toro Company is a homegrown, Minnesota-based company that has been in business since 1914. We pride ourselves on providing world-class equipment to help maintain the environment that we love, while putting an emphasis on giving back to the communities that surround us. From residential lawns and gardens, to venues such as St Andrews Links...

  • Quality Assurance Manager

    10 hours ago

    Bloomington, Indiana, United States Cypress HCM Full time

    Job DescriptionCypress HCM is a leading manufacturer and supplier of medical devices based in the Monroe, WA area.This exciting role will work with the quality assurance, quality control, and operations team to ensure that products are manufactured safely with the highest level of quality promptly that meets or exceeds customer and regulatory...

  • Sr Site Reliability Engineer

    6 months ago

    Bloomington, United States SAS Full time

    Sr Site Reliability Engineer Job Locations US-MN-Bloomington Requisition ID 20060806 Category IDeaS (a SAS company) Position Type Contractor Passionate people. Loyal clients. Leading solutions. With a rich culture of creative collaboration and professional growth, IDeaS’ team members build successful careers with us. IDeaS is proud to be a global...

  • Quality Engineer, CAPA

    4 weeks ago

    Bloomington, United States Cook Group Full time

    Overview The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities. Responsibilities • Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Conduct Risk-based decision making and effective resolution of issues• May interface with...

  • Senior Quality Engineer

    1 week ago

    Bloomington, Indiana, United States Cook Group Full time

    Job SummaryWe are looking for a highly qualified Senior Quality Engineer to support the development and implementation of quality systems. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards, including ISO 13485 and FDA 21 CFR 820. Key responsibilities include developing and implementing...