Lead Quality Assurance Engineer

2 weeks ago


Big Lake, Minnesota, United States TOMZ Corporation Full time

TOMZ Corporation is seeking a dedicated Senior Quality Assurance Engineer – Sustained Manufacturing to enhance our team. As a prominent player in the production of devices and components for leading medical device firms, TOMZ provides competitive salaries and comprehensive benefits, including 401k, health/dental, vision, and paid time off. Our facility is modern, clean, and safe, equipped with cutting-edge technology and a commitment to ongoing process enhancement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and holds ISO 13485 certification.

POSITION OVERVIEW:

This role is pivotal in overseeing the Quality Sustained Manufacturing processes for commercial products and ensuring the effective transition of Development programs to standard production. This will involve leadership, mentorship, and technical support for cross-functional Engineering teams. The successful candidate will be instrumental in formulating and executing strategies for Quality System enhancements.

KEY RESPONSIBILITIES:

  • Lead the creation and/or revision of Risk Management FMEA documentation in collaboration with cross-functional engineering teams based on project specifications.
  • Assist in operational and process qualifications for customer manufacturing processes alongside cross-functional engineering teams.
  • Guide the implementation and ongoing enhancement of Incoming Inspection, First Article Inspection, In-Process, and Final Product Inspection protocols.
  • Ensure the continuous optimization and advancement of Test/Inspection Methods.
  • Develop and validate suitable sampling plans, including the characterization of test/inspection methods and acceptance criteria.
  • Utilize effective, systematic problem-solving techniques to identify, prioritize, communicate, and resolve quality challenges, including CAPAs, Complaints, and NCRs.
  • Fulfill additional responsibilities as detailed in the complete job description.

REQUIREMENTS:

Education:

· A minimum of a 4-Year degree or equivalent directly relevant industry experience (preferably in Engineering or Quality disciplines).

Experience:

· At least 7 years of experience in a regulated manufacturing setting.



  • Big Lake, Minnesota, United States TOMZ Corporation Full time

    TOMZ Corporation is seeking a dedicated Senior Quality Assurance Engineer – Sustained Manufacturing to enhance our team. As a prominent player in the production of devices and components for leading medical device firms, TOMZ provides attractive compensation packages along with comprehensive benefits. These benefits include 401k plans, health/dental...


  • White Bear Lake, Minnesota, United States RTA US Full time

    Job OverviewRTA US is seeking a dedicated and experienced Quality Assurance Engineer to join our dynamic team. This is a permanent position offering a competitive salary in the range of $115,000 to $125,000 annually.Position Summary:The Lead Quality Assurance Engineer is crucial in promoting a culture of excellence and ongoing enhancement throughout the...


  • Forest Lake, Minnesota, United States Cypress HCM Full time

    About the RoleCypress HCM is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services, and for developing and implementing quality assurance processes and procedures.Key ResponsibilitiesQuality Assurance: Develop and...


  • Forest Lake, Minnesota, United States Cypress HCM Full time

    Position Overview:A prominent contract manufacturing and injection molding organization is seeking to appoint a Senior Quality Engineer. This role requires a quality expert who will work entirely onsite and ideally possesses a background in plastic injection molding.Essential Qualifications:Bachelor's degree in engineering or a related discipline, or...


  • Forest Lake, Minnesota, United States Cypress HCM Full time

    Position Overview:A prominent contract manufacturing firm specializing in injection molding is seeking a Lead Quality Assurance Engineer. This role requires a dedicated professional to work onsite, ideally with a background in plastic injection molding.Essential Qualifications:Bachelor's degree in engineering or a related discipline, or equivalent experience...


  • White Bear Lake, Minnesota, United States Vista Technologies Full time

    Job OverviewWe are seeking a dedicated Quality Assurance Specialist to join our team at VistaTek, a family-owned leader in mold making and injection molding.Educational BackgroundRequired:High School diploma or equivalent (GED)Quality training/certifications are advantageousFamiliarity with ISO StandardsProfessional ExperienceEssential: A minimum of three...


  • Ham Lake, Minnesota, United States FATHOM Full time

    Company Overview:Fathom stands as a leader in the digital manufacturing sector, providing on-demand production solutions across North America. With a robust fleet of over 90 industrial-grade 3D printing machines and a vast operational footprint exceeding 500,000 square feet across 10 facilities, Fathom integrates a diverse range of in-house capabilities,...


  • Prior Lake, Minnesota, United States Gaming Enterprise Full time

    Job Overview:We are seeking a detail-oriented Hotel Room Quality Assurance Specialist to join our Gaming Enterprise team. As a key member of our Housekeeping Team, you will be responsible for ensuring the highest quality standards are met in our hotel rooms and public areas.Key Responsibilities:Conduct thorough inspections of hotel rooms and public areas to...

  • Design Engineer

    1 week ago


    Big Lake, Minnesota, United States Anderson Dahlen Full time

    About the RoleAnderson Dahlen is a leading provider of metal fabrication and equipment integration services to various industries.Key ResponsibilitiesDesign and develop fabricated components and systems for manufacturability, ensuring they meet customer expectations and regulatory requirements.Collaborate with operations, sourcing, quality, and project...


  • Big Lake, Minnesota, United States Luxe Autos Full time

    Job SummaryWe are seeking a skilled Automotive Technician to join our team at Luxe Autos. As an Engine Specialist, you will be responsible for performing engine and transmission swaps with precision and efficiency.Key Responsibilities:Diagnose and troubleshoot complex mechanical issues related to engines and transmissions.Collaborate with the team to ensure...


  • Ham Lake, Minnesota, United States FATHOM Full time

    Company Overview:Fathom stands as a leading digital manufacturing platform, providing on-demand production solutions across North America. With a robust fleet of over 90 advanced industrial-grade 3D printing machines and a vast operational footprint exceeding 500,000 square feet across 10 facilities, Fathom integrates a wide array of in-house capabilities,...


  • Ham Lake, Minnesota, United States FATHOM Full time

    Company Overview:Fathom stands as a leading digital manufacturing platform in North America, specializing in on-demand production. With a robust fleet of over 90 large-scale industrial 3D printing machines and an expansive operational footprint exceeding 500,000 square feet across 10 facilities, Fathom integrates diverse in-house capabilities, including...


  • Big Lake, Minnesota, United States Aerotek Full time

    Job OverviewPosition: Mechanical Assembly Technician ($18-21/hr)As a Mechanical Assembly Technician, your primary responsibilities will include sourcing materials from our inventory, assembling various devices, performing quality assurance tests, and diagnosing any issues that arise during the assembly process.You will collaborate with a dedicated team of...

  • Assembly Technician

    7 days ago


    Big Lake, Minnesota, United States Engage Technologies Full time

    Job SummaryWe are seeking a skilled Mechanical Assembler to join our team at Engage Technologies. As a key member of our production team, you will be responsible for assembling machines, equipment, and their sub-assemblies according to customer specifications.Key ResponsibilitiesAssembly Process:Assemble machines, including sealers, tunnels, and...


  • Big Lake, Minnesota, United States Engage Technologies Full time

    Job SummaryWe are seeking a skilled Mechanical Assembler to join our team at Engage Technologies. As a key member of our production team, you will be responsible for assembling machines, equipment, and their sub-assemblies according to customer specifications.Key ResponsibilitiesAssembly Process:Assemble machines, including sealers, tunnels, and...


  • Lake Elmo, Minnesota, United States Conagra Brands Full time

    Job SummaryThe Food Safety and Quality Manager will be responsible for ensuring the quality and safety of all products produced in the plant. This individual will work closely with the Director of Food Safety Quality to develop and implement quality and safety programs, and will be responsible for ensuring compliance with all applicable food laws and...

  • CNC Machinist I

    3 days ago


    Big Lake, Minnesota, United States Engage Technologies Corporation Full time

    Job SummaryWe are seeking a skilled CNC Machinist I to join our team at Engage Technologies Corporation. As a CNC Machinist I, you will be responsible for programming and operating CNC mills to produce, modify, or repair precision parts.Key Responsibilities:Program and setup CNC mills with the appropriate tooling to produce precision parts.Monitor machine...


  • Big Lake, Minnesota, United States Engage Technologies Corporation Full time

    Position: CNC Machinist I Company Overview: Engage Technologies Corporation is a prominent parent company overseeing various brands, including Squid Ink, Eastey, AFM, and Cogent Technologies. Our divisions specialize in manufacturing innovative solutions for product identification, packaging equipment, and industrial drying systems. Job Summary: The CNC...


  • Big Lake, Minnesota, United States Aerotek Full time

    Aerotek is seeking a skilled Blaster to join their team. As a Blaster at Aerotek, you will be responsible for:Performing Enclosed Blasting Techniques: You will use various blasting methods to prepare surfaces for future processes.Using Blasting Media: You will work with different types of blasting media, such as aluminum oxide, glass beads, and plastic...


  • Big Lake, Minnesota, United States Aerotek Full time

    Job OverviewAerotek is seeking a skilled Production Associate to join our team in a dynamic manufacturing environment. As a key member of our production team, you will be responsible for operating and monitoring molding machinery to create high-quality rubber products.Key ResponsibilitiesOperate and Monitor Molding Machinery: Safely operate and monitor...