Quality Engineering Temp

Job Title: Quality Engineer
Provide 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. 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.
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.
Familiarity with quality system regulations and requirements such as 21 CFR Part 820, ISO 9001.

• 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.
• Ability to work within a team environment and build relationships outside the department as well as with suppliers and regulatory agencies.
• Bachelor's degree in engineering or an alternative Bachelor's degree program.
• 3+ years of experience in an Orthopedic Quality Engineering role.

The position requires 20% travel and is based onsite in Warsaw, working 5 days per week.
This is a Contract to Hire position based out of Warsaw, IN.
If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• 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)
• Employee Assistance Program
• Application Deadline

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.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 View email address on click.appcast.io 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.