Quality Engineer

Actalent; Warsaw (IN); On-site; USD 55,000 - 80,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

HSA

Job summary

Actalent in Warsaw, IN is seeking a Quality Engineer to drive data‑driven quality improvements in a regulated medical device environment. You will conduct audits, inspections, and tests, collaborate with Manufacturing, Sourcing, and Development, and lead projects with realistic timelines to ensure products meet standards.

The role requires hands‑on experience in ISO and QSR compliance, root cause analysis, and auditing, with an emphasis on cross‑functional teamwork and continuous improvement.

Qualifications

• Quality engineering experience in a regulated environment.
• Experience with ISO standards and QSR requirements.
• Experience with audits, inspections, and tests.
• Analysis of processes to ensure compliance and performance.

Responsibilities

• Gathers data to identify and solve quality problems.
• Plans and leads quality projects with realistic timelines.
• Evaluates processes and equipment for performance and quality.
• Establishes quality plans for equipment and processes.
• Monitors processes against standards and acts on deviations.
• Ensures products conform to requirements via audits and tests.
• Collaborates with suppliers and internal teams on quality.
• Interprets regulations with Manufacturing, Sourcing, and Development.
• Maintains budgets for quality engineering activities.
• Fosters a team-oriented environment across departments.

Skills

Quality engineering

Medical device quality

ISO & QSR knowledge

Project planning

Cross-functional collaboration

Data-driven decision making

Audits and inspections

Root cause analysis

Education

Bachelor of Science in Engineering or CQE

Job description

Job Title: Quality EngineerJob Description

The Quality Engineer gathers and analyzes factual data to solve quality-related problems and ensure that products consistently meet established requirements and standards. This role identifies and implements solutions using technical experience and established precedents, plans and leads projects with realistic timelines, and fosters a collaborative team atmosphere across departments. The Quality Engineer conducts audits, inspections, and tests, and works closely with internal functions, suppliers, and external experts to achieve and maintain high quality and regulatory compliance.

Responsibilities

• Gather relevant, factual information and data to identify, analyze, and solve quality-related problems.
• Resolve quality issues by identifying and applying solutions derived from technical experience and guided precedents.
• Plan and lead quality-related projects by defining activities, sequencing tasks, and establishing realistic timelines.
• Evaluate process methods and equipment to ensure they meet performance and quality requirements.
• Establish quality plans for equipment and processes to support general and specific product performance needs.
• Monitor the performance of processes against established standards and take action when deviations occur.
• Assure that products conform to established requirements and standards through appropriate audit, inspection, and test activities.
• Apply ISO and Quality System Regulation (QSR) requirements to internal processes and procedures, as well as those of external suppliers.
• Collaborate with suppliers on new product introductions to ensure quality and performance requirements are fully met.
• Assist Manufacturing, Sourcing, and Development teams in interpreting and applying relevant regulations and quality requirements.
• Interact with multiple functional departments, suppliers, and external experts to implement quality goals and continuous improvement initiatives.
• Develop and maintain department and project budgets to support quality engineering activities and objectives.
• Promote a team-oriented environment and work productively with all departments to achieve shared quality goals.

Essential Skills

• Proven experience in quality engineering, with 57 years in a Quality Engineering role or an equivalent combination of education and experience.
• Strong background in quality engineering within the medical device industry, strongly preferred.
• Bachelor of Science in engineering or an alternative bachelors degree with certification as a quality engineer (e.g., CQE).
• Demonstrated ability to evaluate process methods and equipment for compliance with performance and quality requirements.
• Experience establishing and maintaining quality plans for equipment and processes.
• Hands‑on experience monitoring process performance and implementing corrective actions to maintain established standards.
• Proficiency in applying ISO standards and Quality System Regulation (QSR) requirements to processes and procedures.
• Ability to interpret and apply regulatory requirements in partnership with Manufacturing, Sourcing, and Development teams.
• Experience conducting audits, inspections, and tests to verify product and process conformance.
• Strong project planning and leadership skills, including organizing activities into time‑dependent sequences with realistic timelines.
• Ability to develop and manage department and project budgets.
• Effective collaboration and communication skills for working with cross‑functional teams, suppliers, and external experts.
• Familiarity with Failure Modes and Effects Analysis (FMEA) and related quality tools.

Additional Skills & Qualifications

• Certification as a Quality Engineer (CQE) granted through the American Society for Quality (ASQ) or equivalent is preferred.
• Reliability Engineer Certification (CRE) granted through ASQ is preferred.
• Combination of education and experience may be considered in evaluating overall qualifications.
• Experience in medical device quality engineering, including working with suppliers on new product introductions, is highly desirable.
• Ability to foster a team atmosphere and work productively with multiple departments.
• Strong analytical and problem‑solving skills with a focus on data‑driven decision‑making.

Work Environment

This position is 100% onsite in Warsaw, Indiana. The role involves close collaboration with manufacturing, sourcing, development, and supplier teams within a regulated environment that adheres to ISO standards and Quality System Regulations. The work setting is primarily within a production and office environment where the Quality Engineer participates in audits, inspections, and process evaluations, and regularly interacts with cross‑functional teams and external partners.

Job Type & Location

This is a Contract position based out of Warsaw, IN.

Pay and Benefits

The pay range for this position is $40.00 - $58.00/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 24, 2026.

Workplace Type

This is a fully onsite position in Warsaw,IN.

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.