Quality Assurance Specialist

7 days ago

Bloomington, Indiana, United States Cypress HCM Full time
Job Summary

Cypress HCM is a leading manufacturer and supplier of medical devices headquartered in the Monroe, WA area. We are seeking a Quality Assurance Specialist to join our team. The successful candidate will work with the quality assurance, quality control, and operations team to ensure that products are manufactured safely with the highest level of quality promptly that meets or exceeds customer and regulatory requirements.

About the Role

This exciting role offers an opportunity to lead quality processes and be passionate about the medical device industry. As a Quality Assurance Specialist, you will be responsible for ensuring the quality performance of products and processes. You will also oversee and approve Nonconformity (NC) and Corrective and Preventive Actions (CAPA), contribute to the improvement and development of manufacturing processes for existing and new products, and develop and provide input for risk management by identifying opportunities and weaknesses.

Responsibilities
  • Collaborate with the operations and business teams to ensure quality performance of products and processes.
  • Oversight and approval of NC and CAPA.
  • Contribute to and lead the improvement and development of manufacturing processes for existing and new products.
  • Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Responsible for review and approval of process and equipment validation and qualification.
  • Analyze and review concession requests.
  • Review and approve change management activities as necessary.
  • Maintain KPIs for monitoring process quality, interpreting trends, and performing analysis.
  • Proficient in risk management practices and tools, with high expertise in process risk.
  • Proficiency in and continuous strides towards optimization of inspection methods and sampling.
  • Support First Article Inspections.
  • Participate in internal and external audits with regulatory representatives.
  • Responsible for initiation, management, and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor junior engineers in quality topics and responsibilities.
Qualifications
  • A minimum of 2-3 years of relevant experience in the manufacturing industry or a Master's degree in engineering or a relevant scientific discipline is required.
  • Bachelor's degree in engineering or a relevant scientific field is required.
  • Excellent communication skills and ability to work well with a team are essential.
  • Previous experience with lean tools is preferred.
  • Previous experience with the medical device industry is preferred.
  • Proficiency in statistical methods and root cause analysis is required.
Compensation

The salary range for this position is $75,000-$120,000 depending on experience.

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