Quality Engineer
This role provides lead quality support for new product development teams to ensure new and improved medical device products and processes comply with applicable standards and regulations. The Quality Engineer owns design quality activities to ensure adherence to designcontrol systems, supports Design History File (DHF) creation, and helps drive timely regulatory approvals. The position plans and leads quality projects by organizing activities into realistic timelines and works collaboratively with cross-functional teams to build a strong, team-oriented environment.
Responsibilities
- Provide lead quality support for new product development projects to ensure medical device products and processes comply with applicable standards and regulations.
- Own design quality activities to ensure compliance with design control systems for new and improved products.
- Assist with all elements of the design control system and Design History File (DHF) creation for new product development from a design quality perspective.
- Help execute within a quality assurance system that aligns with the established Quality Management System (QMS) while optimizing time to regulatory approval and clearance.
- Collaborate with suppliers to review and drive engineering drawing reviews, gage development, capability studies, gage R&R studies, special process validations, tolerance stack-ups, CMM correlation studies, PFMEA, process flows, control plans, inspection plans, and Device History Record (DHR) reviews to ensure regulatory clearance and production readiness.
- Develop and implement corrective and preventive action plans, including internal CAPAs and supplier SCARs, to address product and process issues.
- Provide verification and validation, sampling, and statistical analysis support for all functions required for product clearance and approval, including supplier-related activities such as mechanical testing, manufacturing special processes, packaging, and sterilization.
- Design and implement inspection methods, equipment, acceptance criteria, and sampling plans to support and qualify vendors.
- Apply problem-solving methodologies, such as DMAIC, Shainin, and Ishikawa techniques, to identify root causes and implement effective solutions.
- Use statistical tools and software to analyze process data, monitor process control, and assess process capability.
- Interpret engineering drawings, including geometric dimensioning and tolerancing (GD&T), to define appropriate inspection methods and understand limitations based on tolerances.
- Work effectively and productively with all departments, fostering a strong team atmosphere and building relationships within the organization and with external partners such as suppliers and regulatory agencies.
- Communicate clearly in both oral and written form with multiple levels of the organization to report quality status, risks, and project progress.
Essential Skills
- Proven experience as a Quality Engineer in the medical device industry, with strong involvement in new product development.
- Strong experience with Risk Management documentation, including the creation, maintenance, and application of risk files for medical devices.
- Demonstrated experience authoring and designing Design History Files (DHFs), including ownership of DHF structure, content, and compliance.
- Hands-on experience working within design control systems for medical devices.
- Bachelor's degree in an Engineering discipline.
- Knowledge of design control requirements and applicable medical device regulations, including 21 CFR Part 820.
- Working knowledge of quality system regulations and requirements, including 21 CFR Part 820 and ISO-based quality management standards.
- Experience with corrective and preventive action (CAPA) processes and supplier corrective action requests (SCARs).
- Ability to perform verification and validation activities, including sampling strategies and statistical analysis.
- Proficiency in statistics, process control, and process capability analysis.
- Ability to design and implement inspection methods, equipment, acceptance criteria, and sampling plans.
- Strong communication skills, both oral and written, with the ability to interact effectively at multiple organizational levels.
- Demonstrated ability to work collaboratively in a team environment and build productive relationships with cross-functional partners and external suppliers.
Additional Skills & Qualifications
- Approximately 3 years of experience in quality engineering or a closely related role in the medical device industry is preferred.
- Orthopedic medical device experience is highly preferred.
- Experience with Hazard Analysis documentation is a strong plus.
- Familiarity with ISO 9001 and other relevant quality management system standards.
- Experience with problem-solving methodologies such as DMAIC, the Shainin System, and Ishikawa diagrams.
- Experience applying statistics and statistical software (for example, Minitab) for data analysis and decision-making.
- Experience using Computer-Aided Drafting (CAD) software such as NX or SolidWorks to review and interpret engineering designs.
- Strong understanding of Geometric Dimensioning and Tolerancing (GD&T) and its impact on inspection and process capability.
- Experience designing inspection methods and understanding inspection limitations based on engineering drawings and associated tolerances.
- Ability to collaborate effectively with suppliers and regulatory agencies to support product approvals and ongoing compliance.
- Strong organizational skills with the ability to plan and lead projects, sequence tasks, and manage realistic timelines.
Work Environment
The role is primarily onsite in Warsaw, with an expectation of working in the office four days per week for candidates within commuting distance. Remote candidates may be considered if they can be onsite in Warsaw for the first week of the role and travel to the site as project needs require, approximately 20% of the time. The work environment is collaborative and cross-functional, involving close interaction with engineering, quality, manufacturing, and supplier teams, as well as engagement with regulatory agencies. The position involves regular use of statistical analysis tools, CAD software, and quality management systems in a structured, regulated medical device setting.
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 - $53.00/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)
Application Deadline
This position is anticipated to close on Aug 14, 2026.