About this role
Job Title: Quality Engineer Job DescriptionProvide lead quality support for New Product Development Teams to ensure new and improved medical device products and processes comply with applicable standards and regulations. Responsible for design quality to ensure compliance with design control systems. Plan and lead projects by identifying and organizing activities into time-dependent sequences with realistic timelines. Work effectively and productively with all departments by developing a team atmosphere.Responsibilities • Assist all elements of the design control system and Design History File (DHF) creation from a design quality perspective for new product development. • Help execute within a Quality Assurance (QA) system and team that ensures alignment to the Quality Management System (QMS) while optimizing time to regulatory approval or clearance. • Work with suppliers to review and drive the following to ensure regulatory clearance and production readiness: engineering drawing review, gage development, capability studies, gage R&Rs, special process validations, tolerance stack-ups, CMM correlation studies, PFMEA, process flows, control plans, inspection plans, and DHR reviews. • Develop and implement corrective and preventative action plans, internal CAPAs, and supplier SCARs. • Provide verification and validation, sampling, and statistical analysis support for all functions required for product clearance or approval through supplier relationships, including mechanical testing, manufacturing special processes, packaging, and sterilization. • Design and implement inspection methods, equipment, acceptance criteria, and sampling plans to support qualified vendors. Essential Skills • Knowledge of design control requirements per applicable standards and 21 CFR Part 820. • Familiarity with quality system regulations and requirements such as 21 CFR Part 820, ISO 9001. • Proficiency in problem-solving using root cause methodologies like DMAIC, The Shainin System, and Ishikawa. • Understanding of statistics, process control, and process capability. • Applying statistics and software in data analysis, such as Minitab. • Application of risk management ISO and failure modes and effects analysis (FMEA). • Use of Computer-Aided Drafting Software packages like NX, Solidworks. • Knowledge of Geometric Dimensioning and Tolerancing (GD&T). • Ability to work within a team environment and build relationships outside the department as well as with suppliers and regulatory agencies. • Effective oral and written communication skills across multiple levels of the company. • Bachelor's degree in engineering or an alternative Bachelor's degree program. • 3+ years of experience in an Orthopedic Quality Engineering role. Additional Skills & Qualifications • Combination of education and experience may be considered relative to requirements. Work EnvironmentThe position requires 20% travel and is based onsite in Warsaw, working 5 days per week.Job Type & LocationThis is a Contract to Hire position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $40.00 - $52.00/hr.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 Warsaw,IN. Application DeadlineThis position is anticipated to close on Jul 13, 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 [email protected] 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.