Description:

The Process Quality Engineer will be responsible for ensuring that all manufacturing processes meet the stringent quality standards required for Class III medical devices. This role involves developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory requirements and industry standards.

Skills:

Quality engineering, Quality assurance, Supplier quality, Ppap, Root cause analysis, Audit, Medical device, Capa, Quality control, Quality management, Iso 13485, Pfmea

Additional Skills & Qualifications:

- Develop and implement process validation protocols and reports (IQ, OQ, PQ) to ensure manufacturing processes are capable and compliant.

- Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address process-related quality issues.

- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure product quality and compliance.

- Monitor and analyze process performance data to identify trends and areas for improvement.

- Lead process improvement initiatives to enhance product quality, reduce waste, and increase efficiency.

- Ensure compliance with FDA regulations, ISO 13485, and other applicable standards.

- Participate in internal and external audits, providing necessary documentation and support.

- Train and mentor production staff on quality standards and best practices.

Additional Information:

We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

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. This temporary role may be eligible for the following:

Medical, Dental & Vision401(k)/RothBasic/Supplemental Life & AD&DShort and long-term disabilityHSA & DCFSATransportation benefitsEmployee Assistance ProgramCompany Paid Time off or State Sick LeaveAbout 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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.