At least 5 years
The Lead Quality Engineer will oversee day-to-day quality systems for a Class II medical device within a small, collaborative team in the Twin Cities. This role manages the Quality Management System (QMS), including CAPAs, change reports, continuous improvement initiatives, and test method validations for on-market products. The position focuses on post-market quality and quality assurance, while offering the opportunity to grow into design assurance responsibilities and gain hands-on leadership experience in a smaller medical device organization.
Responsibilities- Oversee and manage the Quality Management System (QMS) for Class II medical devices, ensuring compliance with applicable standards and regulations.
- Lead and maintain Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness verification.
- Review and manage change reports and quality documentation to ensure accurate, compliant, and timely updates to quality records.
- Drive continuous improvement activities focused on enhancing safety, improving quality cycle times, and reducing lead times to minimize waste.
- Lead the implementation and effectiveness evaluation of continuous improvement systems and methodologies across the quality function.
- Develop, conduct, and control production processes in collaboration with manufacturing teams and quality inspectors to ensure products meet specifications and quality standards.
- Improve measurement and process capability through activities such as gage R&R, test method validation (TMV), statistical process control (SPC), and design of experiments (DOE).
- Initiate and manage nonconforming product or material review board activities, including disposition decisions and follow-up actions.
- Support post-market quality activities for on-market products, including monitoring product performance and implementing quality improvements.
- Collaborate closely with manufacturing and other cross-functional development teams to support product and process improvements.
- Provide day-to-day guidance and oversight to a quality associate, helping to manage workload, priorities, and professional development.
- Work alongside another quality engineer and report to the director of quality, contributing to a cohesive and high-performing quality team.
- Participate in audits and quality control activities to maintain robust quality assurance practices.
- Support and potentially expand into design assurance responsibilities, contributing to risk management and design-related quality activities as experience grows.
- 35 years of experience as a Quality Engineer in a regulated environment.
- At least 3 years of hands-on experience managing and executing CAPA processes.
- Minimum of 3 years of experience working within a formal Quality Management System (QMS).
- At least 5 years of experience in the medical device industry, preferably with Class II devices.
- Strong knowledge of quality engineering principles, including quality control and quality assurance in a manufacturing environment.
- Experience with test method validation (TMV), gage R&R, statistical process control (SPC), and design of experiments (DOE).
- Demonstrated ability to lead continuous improvement initiatives focused on safety, quality, and waste reduction.
- Experience with audits and compliance activities related to medical devices.
- Proven ability to collaborate with manufacturing and cross-functional teams to improve processes and product quality.
- Exposure to or experience in design assurance is a plus, with the potential to grow into a dedicated design assurance role.
- Experience supporting post-market quality activities for on-market products.
- Ability and interest in gaining management experience by overseeing and mentoring a quality associate.
- Strong analytical and problem-solving skills with a focus on root cause analysis and data-driven decision-making.
- Effective communication skills for working with quality, manufacturing, and other internal teams.
- Motivation to work in a smaller medical device company environment with opportunities for broader responsibility and career growth.
The role is based onsite in an office located in Eden Prairie, working Monday through Friday. The quality team is small and collaborative, currently consisting of a director of quality and a quality associate, with this position joining as the third team member. The Lead Quality Engineer will work closely with another quality engineer, the associate, and cross-functional teams such as manufacturing and development. After initial training, there may be some flexibility in work arrangements. The environment offers exposure to a broad range of quality activities, opportunities to gain leadership experience, and close collaboration across departments within a growing medical device organization.
Job Type & LocationThis is a Contract position based out of Eden Prairie, MN.
Pay and BenefitsThe pay range for this position is $43.00 - $52.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Eden Prairie,MN.
Application DeadlineThis position is anticipated to close on Oct 16, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006334242