Duties and Responsibilities
- Lead investigations of quality issues, including internal nonconformities and customer complaints. Manage Corrective and Preventative Action (CAPA) activities, including root cause analysis, solution identification, implementation, and effectiveness verification.
- Own the CAPA process and identify opportunities to improve its effectiveness, efficiency, and cross-functional coordination.
- Analyze quality data, communicate trends to cross-functional teams, and identify opportunities for product and process improvement.
- Develop and implement effective measurement and inspection methods. Establish systems for data collection, management, and monitoring to support data-driven decision-making and problem-solving.
- Support new product development activities by defining inspection processes and providing training to ensure product quality, performance, and regulatory compliance requirements are met.
- Collaborate with engineering and production teams to establish appropriate sampling plans for evaluating product and process quality.
- Participate in internal and external audits; determine appropriate corrective and preventative actions to address audit findings
- Support process verification and validation activities, including the development and execution of IQ, OQ, and PQ protocols and reports.
- Provide technical guidance to engineers, technicians, and cross-functional teams on quality principles, best practices, and problem-solving methodologies.
- Perform additional responsibilities as requested to achieve business objectives
Qualifications
- BS degree in Engineering, Quality, or a related field, with 3-5 years of experience
- Experience with medical devices or other highly regulated industries/products desired
- Demonstrated ability to work and make decisions independently and lead others to the completion of assigned tasks
- Demonstrated ability to communicate effectively both verbally and in written form
Physical Requirements:
- Must be able to sit, stand, and/or walk for up to 8-10 hours per day
- Must be able to occasionally lift up to 25 pounds
- May require occasional early morning or late evening teleconferences
- May require occasional visits to suppliers
Equal Opportunity Employer
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