Location
Warsaw, IN | United States
Job description
Job Responsibilities
- This role is crucial for supporting the organization in meeting both quality and production objectives
- By employing an engineering approach, the Quality Engineer will work towards enhancing manufacturing efficiencies and ensuring that all product quality standards are consistently met
- Act as a quality representative for assigned manufacturing areas and/or customers, ensuring compliance with customer requirements, and industry regulations, including FDA Quality System Regulation and ISO 13485
- Support the Material Review Board process in collaboration with operations and engineering teams
- Provide ongoing quality engineering support to operations, including risk management, development of inspection requirements, and investigation of complaints, non-conformances, and Corrective and Preventive Actions (CAPA)
- Handle submission of documentation to customers for new product launches and requests for documentation on legacy products
- Demonstrate commitment to continuous improvement by identifying opportunities and recommending enhancements to the quality system and manufacturing processes
- Establish effective corrective action plans and lead in the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Recommend test methods and statistical process control procedures for achieving required levels of product reliability
- Participate in testing and data analysis, including capability studies and Gage R&R studies, to ensure new processes meet acceptance criteria
- Leadership in developing quality-related processes and initiatives
- Monitoring of complaint trends and data to escalate emerging issues appropriately
- Implementation of effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements
Qualifications
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
- 4+ years' of industry experience
- Strong knowledge of quality tools used in the industry
- Analytical and quantitative approach to problem solving
Contact your Recruiter:
For more information about the role and to express your interest, you can reach out to our recruiter, Lauren Keltz, directly:
Email: [email protected]
Phone: 339-800-4995
About Harba Solutions:
Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.
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