Senior Quality Assurance Consultant for Medical Devices

5 days ago


Grand Blanc, Michigan, United States Ventura Solutions LLC Full time
Job Summary

We are seeking a seasoned Senior Quality Assurance Consultant to join our team at Ventura Solutions LLC. As a Senior Quality Assurance Consultant, you will be responsible for providing quality engineering support for new product development projects in the medical device industry.

Responsibilities
  • Design Control Activities: You will serve as the design quality engineering resource for design projects, ensuring compliance with applicable internal and external requirements during the product development cycle.
  • Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process.
  • Responsible for Quality Engineering deliverables required within the product development process, including review and analysis of verification & validation protocols and reports.
  • Support Design Verification and Validation activities, including review of verification & validation protocols and reports, and participate in product design reviews and team meetings.
Requirements
  • Bachelor's degree in science or engineering.
  • Minimum of 5 years of quality engineering or related experience in an FDA regulated medical device environment.
  • Proficiency with medical device development life cycles and Design Control processes preferred.
  • Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
  • Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Knowledge of IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred.
  • Medical Device and/or Combination Products experience.
  • Ability to write Verification / Validation protocols and reports.
  • Problem solver.
  • Six sigma green belt and/or ASQ CQE preferred.
  • Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
  • Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally with internal and external partners and regulatory bodies.

The estimated salary range for this position is $80,000 - $110,000 per year, depending on experience, location (remote), and other factors. We offer a comprehensive benefits package, including choice of medical, dental, and vision plans, paid vacation time, and 401(k) matching.



  • Grand Haven, Michigan, United States The Pivot Group Full time

    Job SummaryWe are seeking a seasoned professional with expertise in quality assurance to join our team as a Senior Quality Engineer.About the RoleThe ideal candidate will have a proven track record of implementing comprehensive quality control systems and standards, monitoring quality performance metrics, and leading cross-functional teams to address quality...


  • Grand Rapids, Michigan, United States X-Rite Full time

    We are seeking a skilled Software Quality Assurance Professional to join our team at X-Rite. This role will be responsible for ensuring the quality of our software products throughout the entire development process.Key ResponsibilitiesDevelop and execute comprehensive testing strategies to verify software meets quality standardsCollaborate with...


  • Grand Rapids, Michigan, United States Johnson Controls Full time

    Unlock Your Potential as a Senior Security Systems ConsultantWe are seeking an experienced Senior Security Systems Consultant to join our team at Johnson Controls. This role will involve providing technical support to security sales associates, conducting on-site assessments, and developing security equipment estimates and project design deliverables.About...


  • Grand Blanc, Michigan, United States Premier Medical Staffing Full time

    Premier Medical Staffing is a leading healthcare staffing firm that places highly qualified medical professionals in various healthcare settings. We are currently seeking a highly skilled Cath Lab Technologist to fill a travel position in a Michigan facility.About the JobAs a Cath Lab Technologist with Premier Medical Staffing, you will be responsible for...


  • Grand Blanc, Michigan, United States Aequor Full time

    About AequorAequor is a leading healthcare organization dedicated to providing exceptional medical imaging services. We are seeking an experienced Senior Medical Imaging Specialist to join our team in Grand Blanc, MI.CompensationThe estimated annual salary for this position is approximately $122,440, based on the average gross weekly pay of $2,355.20 and a...


  • Grand Rapids, Michigan, United States Aerotek Full time

    OverviewAerotek is a leading staffing agency connecting skilled trades workers with top employers across North America. We are seeking experienced Cleanroom Assemblers to join our team in Grand Rapids, MI.Salary and BenefitsThe pay range for this position is $17.00 per hour, with opportunities for growth and regular merit increases. Employees also enjoy...


  • Grand Rapids, Michigan, United States Aerotek Full time

    We are seeking experienced cleanroom assemblers to join our team in Grand Rapids, MI. The role involves working in a clean room environment where you will be responsible for the light assembly of medical devices, particularly those used in cardiac surgeries.Job ResponsibilitiesPerform light assembly of small equipment and components for cardiac surgery...


  • Grand Rapids, Michigan, United States Ascential Technologies Full time

    Ascential Technologies is seeking a Quality Assurance Professional to join our team. The estimated salary for this position is $95,000 per year.About the JobWe are looking for an experienced Quality Engineer 2 who can lead audit activities and provide critical input on work instructions. The ideal candidate will have strong analytical skills, a solid...


  • Grand Rapids, Michigan, United States Robert Half International Full time

    Job Title: Senior Financial ConsultantWe are seeking a skilled and experienced Senior Financial Consultant to join our team at Robert Half International in Grand Rapids, MI. This role offers an exciting opportunity to leverage your expertise in financial consulting and business development to drive growth and success.About the Role:This position involves...

  • Project Manager

    6 days ago


    Grand Blanc, Michigan, United States JRG Partners Full time

    We are seeking a highly skilled Project Manager to lead our construction projects as a Senior Construction Lead. This role offers the opportunity to drive initiatives from inception to fruition, ensuring they are executed with precision and innovation, safely, on schedule, and within budget.Key Responsibilities:Strategic Project Leadership: Oversee the...


  • Grand Rapids, Michigan, United States Viant, Inc. Full time

    Viant, Inc., a global medical device design and manufacturing services provider, is seeking an experienced Medical Device Packaging Design Engineer to join our team. As a key member of our Packaging Engineering team, you will support the design, development, and maintenance of medical device package systems, production packaging processes, and equipment.Key...


  • Grand Rapids, Michigan, United States Saxon Global Full time

    Saxon Global seeks a seasoned Lead Software Quality Assurance Engineer to spearhead the development of comprehensive quality assurance strategies for our software applications.About Saxon Global:Saxon Global is a global leader in providing innovative solutions to businesses. Our team of experts works tirelessly to deliver high-quality products that exceed...


  • Grand Blanc, Michigan, United States Assured Nursing Full time

    We are seeking a skilled Diagnostic Imaging Specialist to join our team at Assured Nursing. This is a travel opportunity that offers the chance to work in a dynamic environment and expand your professional horizons.About the JobThis 13-week contract position is available in Grand Blanc, Michigan, and requires a minimum of 2 years of recent experience as a...


  • Grand Rapids, Michigan, United States Western & Southern Life Full time

    About the RoleWe are seeking a highly motivated and results-driven Senior Financial Solutions Consultant to join our team at Western & Southern Life.Job DescriptionThis is a unique opportunity to build strong relationships with middle-market clients, analyze their financial needs, and provide tailored solutions to meet their objectives. As a Senior Financial...


  • Grand Blanc, Michigan, United States Vital Tech Solutions Full time

    Job OverviewVital Tech Solutions is a premier full-stack enterprise technology consulting and human capital management solutions provider to various industries. We are seeking a highly motivated and experienced Senior Full Stack Software Engineer to join our team.This role involves designing and developing software, improving existing code, and collaborating...


  • Grand Rapids, Michigan, United States Grand River Aseptic Manufacturing Full time

    We are seeking a Quality Assurance Manager for our Parenteral Liquid Products department at Grand River Aseptic Manufacturing. This role will supervise inspection, labeling and packaging operations to ensure products comply with cGMPs, SOPs, batch record instructions, and labor and material standards.About the RoleThis is a key position in our Finishing...


  • Grand Blanc, Michigan, United States Mattress Firm Full time

    About Mattress FirmWe are America's most trusted authority on sleep, with a mission to help people sleep well to live well. With over 30 years of experience and more than 2,400 stores nationwide, we have helped millions of people get better sleep.Salary RangeThe estimated salary for this role is $50,000 to $60,000 per year, based on national averages.Job...


  • Grand Blanc, Michigan, United States OneStaff Medical Full time

    About the RoleOneStaff Medical is seeking a skilled Traveling Telemetry Nurse to join their team for a 13-week assignment in Michigan.Job OverviewA Telemetry Nurse plays a vital role in patient care, monitoring vital signs and providing medical support to patients with acute diagnoses. This position requires strong communication skills and the ability to...


  • Grand Blanc, Michigan, United States Tyche Project Full time

    About Tyche ProjectTyche Project is an innovative insurtech start-up revolutionizing the insurance industry with cutting-edge solutions.We're looking for a skilled Senior Software Engineer to join our team and contribute to the development of high-quality software solutions.Key Responsibilities:Design and develop high-quality software solutions with minimal...


  • Grand Blanc, Michigan, United States Pkaza Full time

    About the RoleThis is a challenging and unique opportunity to work as a Senior Electrical Design Engineer with Pkaza LLC. The successful candidate will be responsible for designing critical power systems for new data centers and expansions to existing data centers.The ideal candidate will have past experience designing electrical systems specifically for...