Quality Engineer

Actalent; Portage (MI); Híbrido; USD 44 000 - 63 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Transportation benefits

PTO / Vacation

Resumo da oferta

Actalent in Portage, MI is seeking a Divisional Quality Engineer to strengthen product reliability across the lifecycle. This hybrid role combines on-site collaboration Tue–Thu with remote work Mon and Fri, supporting post-market insights and design improvements for healthcare products worldwide.

You will lead cross-functional teams, perform root-cause analysis, update risk docs, and guide R&D through quality systems to ensure regulatory compliance. Contract position with competitive benefits.

Qualificações

• Quality engineering experience.
• Corrective and preventive action experience.
• Complaint investigation skills.
• Good communication skills (2+ years).
• Documentation and print review (2+ years).
• Quality investigation experience (2+ years).
• NC/CAPA experience, preferably in TrackWise (1+ years).
• Data trending experience.

Responsabilidades

• Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records.
• Support business units and commercial teams by providing post-market quality expertise and technical guidance.
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership.
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness.

Conhecimentos

Quality engineering

CAPA experience

Complaint investigation

Communication skills

Documentation review

Quality investigations

TrackWise

Data trending

Formação académica

B.S. in engineering

Ferramentas

TrackWise

Descrição da oferta de emprego

Job Title: Divisional Quality Engineer

As a Divisional Quality Engineer, you will play a critical role in strengthening product reliability across the lifecycle, from post-market insights to product improvements that shape future innovations. This role offers meaningful impact, cross-functional collaboration, and the opportunity to influence products used by healthcare professionals worldwide.

Job Description

As a Divisional Quality Engineer, you will play a critical role in strengthening product reliability across the lifecycle, from post-market insights to product improvements that shape future innovations. This role offers meaningful impact, cross-functional collaboration, and the opportunity to influence products used by healthcare professionals worldwide.

Responsibilities

• Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records.
• Support business units and commercial teams by providing post-market quality expertise and technical guidance.
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership.
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness.

Essential Skills

• Quality engineering experience
• Corrective and preventive action experience
• Complaint investigation skills
• Good communication skills (2+ years)
• Documentation and print review (2+ years)
• Quality investigation experience (2+ years)
• NC/CAPA experience, preferably in TrackWise (1+ years)
• Data trending experience

Additional Skills & Qualifications

• BS in engineering
• Experience in the medical device or pharmaceutical industry preferred
• Familiarity with ISO standards

Work Environment

This position follows a hybrid work model with on-site work from Tuesday to Thursday and remote work on Monday and Friday. The work environment is collaborative, involving cross-functional teams and the use of various technical tools and documentation systems.

Job Type & Location

This is a Contract position based out of Portage, MI.

Pay And Benefits

The pay range for this position is $39.00 - $39.00/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)

Application Deadline

This position is anticipated to close on Oct 29, 2026.

Workplace Type

This is a hybrid position in Portage,MI.

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 [e-mail] 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.