Director Quality Engineer Fda Jobs in Indiana (NOW HIRING)

The Quality Engineer supports the mission of delivering high‑performance medical wire and components by driving quality excellence across CAPA processes, GD&T inspection, and vendor product quality assurance. This role works closely with cross‑functional teams to ensure compliance with regulatory standards and customer expectations, while maintaining robust quality systems and documentation.

Responsibilities

• Lead and support investigations for non-conformances and customer issues, performing thorough root cause analysis using tools such as 5 Whys, fishbone diagrams, and FMEA.
• Develop and implement effective Corrective and Preventive Action (CAPA) plans that address identified root causes and prevent recurrence.
• Monitor CAPA effectiveness, track progress, and ensure timely closure of all actions.
• Maintain complete and accurate CAPA documentation in accordance with ISO standards, FDA Quality System Regulations (QSR), and internal quality system requirements.
• Interpret engineering drawings and specifications that include Geometric Dimensioning and Tolerancing (GD&T) annotations.
• Perform detailed dimensional inspections using coordinate measuring machines (CMM), calipers, micrometers, and other precision metrology tools.
• Document inspection results clearly and ensure full traceability of measurements and inspection records.
• Collaborate with design and manufacturing teams to resolve GD&T-related issues and ensure that product designs meet functional and quality requirements.
• Support validation and verification activities for new and modified products, ensuring that quality and regulatory requirements are met.
• Conduct incoming inspections and quality audits of vendor-supplied products to verify conformance to specifications and standards.
• Review and approve supplier quality documentation, including Production Part Approval Process (PPAP) submissions, First Article Inspections (FAI), and Certificates of Analysis (COA).
• Communicate quality issues to vendors in a clear and timely manner and support them in developing and implementing effective corrective actions.
• Monitor supplier performance metrics and initiate supplier improvement plans when necessary.
• Ensure that all products and supplier processes comply with applicable regulatory, customer, and internal company-specific quality standards.
• Contribute to continuous improvement initiatives within the quality function by leveraging quality engineering tools and best practices.

• 5+ years of experience as a Quality Engineer with a STEM degree, or 10+ years of substantive Quality Engineering experience without a degree (degree preferred).
• Proven experience with quality documentation and CAPA support, including root cause analysis, corrective action planning, and quality system compliance.
• Hands-on experience with Geometric Dimensioning and Tolerancing (GD&T) testing and documentation.
• Ability to interpret engineering drawings and specifications that use GD&T.
• Experience collaborating with design and manufacturing teams to resolve GD&T-related and quality-related issues.
• Demonstrated experience reviewing and auditing PPAP submissions and related supplier quality documentation.
• Experience in supplier quality, including quality inspection and vendor product quality assurance.
• Proficiency in root cause analysis methodologies, including 5 Whys, fishbone diagrams, and FMEA.
• Strong background in quality engineering within a regulated environment, with familiarity with ISO standards and FDA QSR requirements.
• Ability to perform dimensional inspections using CMMs, calipers, micrometers, and other precision metrology tools.
• Strong documentation skills, with the ability to maintain accurate, traceable, and compliant quality records.

• STEM degree is preferred for candidates with 5+ years of Quality Engineering experience.
• ASQ certification is a nice-to-have and demonstrates a commitment to professional quality standards.
• Experience with Production Part Approval Process (PPAP), First Article Inspection (FAI), and Certificates of Analysis (COA) review.
• Familiarity with supplier performance monitoring and supplier improvement initiatives.
• Comfort working within structured quality systems aligned with ISO and FDA QSR requirements.

The role operates in a regulated manufacturing and quality environment focused on high-performance medical wire and components. The Quality Engineer works closely with design, manufacturing, and supplier teams and regularly uses precision metrology equipment such as CMMs, calipers, and micrometers to perform inspections. The position involves extensive interaction with formal quality systems and documentation aligned with ISO standards and FDA Quality System Regulations, as well as routine review of supplier documentation such as PPAP, FAI, and COA. The work environment emphasizes compliance, accuracy, and collaboration across cross-functional teams to ensure consistent product quality and adherence to regulatory and customer requirements.

Job Type & Location

This is a Contract to Hire position based out of Fort Wayne, IN.

The pay range for this position is $35.00 - $45.00/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)

This is a fully onsite position in Fort Wayne,IN.

This position is anticipated to close on Jul 28, 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 actalentaccommodation@actalentservices.com 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.