Quality Assurance Process Lead

About Us:

CARR Biosystems is a growing business providing critical technology for cutting-edge life science innovations. Our customers are inventing tomorrow’s solutions to treat and cure disease, and our centrifuge technology is enabling it. We’re part of a $3.3 billion parent company (Barry-Wehmiller) where culture is a priority. Our goal is to have performance and people in harmony – and we believe work should be fun, we should inspire our teammates, and each team member is someone’s precious child. We feel it’s a unique opportunity to build the future of CARR Biosystems. If this excites you, please read on…

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

• Create and implement processes to integrate a preventative quality assurance approach through CARR’s operations.
• Engage key stakeholders in other departments to identify and address areas of process and/or product weakness that could expose CARR and CARR’s customers to the risk of failure and the possible loss of production in their operations.
• Ensure that ISO procedures and SOPs are comprehensive and well-documented.
• Ensure that ISO procedures and SOPs are being followed via training records as well as periodic internal audits.
• Provide and maintain monthly KPIs for the Quality Assurance function and help automate them wherever possible.
• Lead/execute root cause/corrective action process to resolve customer complaints and CAPAs in a timely manner with the goal of reducing the current backlog of aged complaints and keeping us current going forward.
• Draft/write CAPA and customer complaint responses.
• Issue SCARs to suppliers and follow-up for responses.
• Help identify opportunities to improve customer experience relative to quality related issues.
• Contribute to new product development/innovation efforts by supporting/promoting Quality by Design.
• Develop Validation Master Plans (VMPs).
• Support required testing activities.
  
  

Required Qualifications:

• Bachelor's Degree in a STEM-related field.
• 5 years of experience in a quality role within a manufacturing environment, preferably with experience in equipment-related manufacturing.
• 2 years of experience conducting root cause analysis, implementing corrective actions, and managing customer complaint investigations, including experience with CAPA (Corrective and Preventive Action) and SCAR (Supplier Corrective Action Request) processes.
• Proven ability to analyze and interpret data within a quality management system.
• 1-2 years of experience developing, writing, and maintaining Standard Operating Procedures (SOPs).
• 1-2 years of experience supporting new product development from a qualification or validation standpoint.
• Strong verbal and written communication skills.
  
  

Preferred Qualifications:

• Experience with ISO 9001, ISO 13485, and/or 21 CFR Part 820 quality management systems.
• Experience conducting internal or external audits.
• ASQ (American Society for Quality) certification (e.g., CQE, CQA).
• Prior experience leading teams or projects.
  
  

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

CARR Biosystems