Senior Quality Assurance Manager

2 weeks ago


Maple Grove, Minnesota, United States Jobleads-US Full time

The Ideal Candidate:

We are looking for a highly motivated and experienced quality assurance manager to join our team. As a Principal Regulatory Affairs Specialist, you will be responsible for ensuring global regulatory compliance across various domains.

Your Key Responsibilities:

  • To lead cross-functional teams to ensure regulatory compliance
  • To develop and implement corrective and preventive actions to address non-conformances
  • To coordinate and manage product incident reports, recalls, and audits
  • To stay up-to-date with changes in regulatory requirements and trends
  • To provide regulatory guidance and support to internal teams

Requirements:

  • Bachelor's degree in a scientific or technical discipline; advanced degree preferred
  • Minimum of 5 years of experience in Regulatory Affairs and/or Quality, with at least 2 years' experience working in Regulatory Affairs, preferably in the medical device industry
  • In-depth knowledge of US regulatory requirements with a preference of international regulatory requirements, including EU MDR, and other global regulations
  • Proven experience in managing PIRs, CAPAs, recalls, and audits
  • Proficiency in regulatory submission software and databases
],
  • Senior Engineer

    2 weeks ago


    Maple Grove, Minnesota, United States TotalMed Staffing Full time

    About this OpportunityTotalMed Staffing is seeking a highly skilled Senior Engineer - Quality Assurance to join our team. In this role, you will be responsible for overseeing the quality of our projects, developing and implementing quality control procedures, and collaborating with team members to achieve shared goals. Your expertise in quality assurance...


  • Maple Grove, Minnesota, United States Konik Inc Full time

    Konik is partnering with a local provider of industrial air filtration solutions seeking an experienced Quality Assurance Manager to develop, implement, and maintain a quality management system (QMS) that ensures compliance with industry standards and enhances customer satisfaction.This role will focus on ISO9001 implementation with design control, quality...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    Job Overview:Boston Scientific is currently recruiting for a Senior Design Assurance Manager to join their team in Maple Grove, MN. As a Senior Design Assurance Manager, you will be responsible for leading a team of Engineers and ensuring product quality and compliance through Design Control and Risk Management.This role requires a strong background in...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    Key ResponsibilitiesAs a DevOps Quality Assurance Manager at Boston Scientific, you will be responsible for ensuring that software quality assurance practices are employed by all departments to ensure that software/firmware-based systems are developed, qualified, and maintained in a manner that provides assurance the system conforms to both internal and...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    About the OpportunityThis position offers a unique chance to harness your skills and experience as a Senior Design Assurance Manager. You will be responsible for leading a team in the Watchman franchise, developing and sustaining implantable and single-use devices for Left Atrial Appendage Closure. Your key focus areas will include:Providing DA leadership...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    About the Role">Boston Scientific is seeking a Senior Software Design Assurance Engineer to join our team in supporting software test activities for a Software as Medical Device (SaMD) product within our Interventional Oncology and Embolization portfolio.">Key Responsibilities">">Ensuring design implementation meets quality standards and strategic business...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    OverviewThe Design Assurance Engineer II will play a key role in ensuring patient safety and quality by supporting commercialized products within the structural heart valves division. The successful candidate will thrive in a culture that prioritizes learning, building lasting relationships with colleagues, and making a positive impact on patients...


  • Maple Grove, Minnesota, United States AdvancedPCB Full time

    Quality Assurance Manager Job DetailsJob Type Full-time Maple Grove, MN Description AdvancedPCB., a leader in PCB manufacturing is seeking a highly motivated Quality Assurance Manager with PCB manufacturing experience, to join our growing team. The Quality Assurance Manager is responsible for ensuring that the product meets established standards of quality...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Maple Grove, Minnesota, United States Nextern Inc. Full time

    Company OverviewNextern Inc. is a dynamic company providing innovative solutions in the Integrated Systems and Therapy Delivery businesses.We are committed to delivering high-quality products and services, and we need a skilled Senior Quality Engineer to help us achieve this goal.Job Description:The Senior Quality Engineer will be responsible for tactical...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Maple Grove, Minnesota, United States US Tech Solutions Full time

    About the Opportunity:The Quality Assurance Lead will be responsible for assuring in the development and execution of streamlined business systems which effectively identify and resolve quality issues.Key Responsibilities:Assure in the development and execution of streamlined business systems.Apply sound, systematic problem-solving methodologies in...


  • Maple Grove, Minnesota, United States Actalent Full time

    About the Job: We are seeking a highly skilled Quality Assurance Professional to join our team at Actalent. The ideal candidate will have a deep understanding of regulatory compliance and quality management principles, with experience in pharmaceutical or medical device industry. As a Quality Assurance Professional, you will be responsible for ensuring that...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    Job DescriptionWe are looking for a talented Senior Design Assurance Manager to join our team at Boston Scientific. As a leader in medical science, we are committed to solving the challenges that matter most - united by a deep caring for human life. The successful candidate will have the following responsibilities:Lead a team of skilled Engineers in the...


  • Maple Grove, Minnesota, United States REO Plastics Inc Full time

    About REO Plastics, Inc.">As a leading custom injection molding company, we've been serving multiple markets in the manufacturing industry for over six decades. Our commitment to forging strong relationships with our employees has been instrumental in our success.">Our Culture">We believe that our employees are our greatest asset. That's why we foster a...


  • Maple Grove, Minnesota, United States Boston Scientific Full time

    About The Position: This Design Quality Assurance Engineer II position offers a unique opportunity to join Boston Scientific's Sustaining Engineering team in Maple Grove, MN. As a key member of this cross-functional team, you'll contribute to ensuring the safety, quality, and compliance of launched products while continuously improving their commercial...


  • Maple Grove, Minnesota, United States US Tech Solutions Full time

    About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality engineering and experience with process control systems, CAPA systems, and NCEP.Key Responsibilities:Develop and implement effective process control systems to support product development and...


  • Maple Grove, Minnesota, United States Entegee Full time

    Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experienceProblem solver, capable of facilitating the problem-solving processAdaptable and effective collaborator in a team environment and...


  • Maple Grove, Minnesota, United States Teleflex Full time

    Position Summary As part of the Teleflex Global Operations Division, and as a member of the Maple Grove Leadership Team, the Sr. Quality Assurance Manager is responsible for managing the site's overall quality system in alignment with the company's global policies. This position drives the execution of deliverables by proactively managing a high-performance...


  • Maple Grove, Minnesota, United States Nextern Inc. Full time

    We are looking for a highly motivated and experienced Senior Quality Engineer to lead our quality efforts. In this role, you will be responsible for overseeing processes such as CAPA, SCAR, process qualification and validation, equipment selection and qualification, process control and yield, trend monitoring, return material authorization, failure analysis...