Overview
This role is pivotal in ensuring the highest quality standards for our medical device production. The Senior Quality Engineer will be responsible for driving production quality initiatives, leading investigations, and maintaining regulatory compliance. The ideal candidate possesses a deep understanding of medical device manufacturing, quality systems, and a strong track record in a Class III environment.
Responsibilities
- Quality Assurance: Develop and implement comprehensive inspection procedures, including sampling plans, for components, sub-assemblies, and finished goods. Lead root cause analysis and corrective action for non-conformances, minimizing product defects and rework.
- Process Excellence: Collaborate with engineering and operations to optimize manufacturing processes. Drive process verification and validation activities, ensuring compliance with regulatory standards and internal quality objectives.
- Documentation and Compliance: Create, review, and approve controlled documents within the electronic document control system. Maintain a strong understanding of regulatory requirements (GMP, ISO, etc.) and ensure adherence to company quality policies.
- Product Release: Oversee product release activities, including review of lot history and sterile load records. Provide training and support to production personnel on quality procedures and standards.
- Cross-functional Collaboration: Work closely with operations, engineering, and other departments to identify and implement quality improvement initiatives.
Qualifications
- Bachelor's degree in engineering or a related scientific field.
- 7-9+ years of quality engineering experience in the medical device industry, with a strong preference for Class III devices.
- Demonstrated expertise in quality systems, including risk management, design controls, and statistical analysis.
- In-depth knowledge of medical device manufacturing processes, inspection methodologies, and quality control tools.
- Strong understanding of process validation, equipment qualification, and sterilization techniques (e.g., EtO).
- Excellent written and verbal communication skills to effectively interact with cross-functional teams.
- Proficiency in relevant software applications (e.g., ERP systems, statistical analysis tools).
Preferred Qualifications
- Experience with sterile barrier packaging and labeling processes.
- Lean Six Sigma certification or equivalent process improvement experience.
- Knowledge of industry standards and regulations (e.g., FDA, ISO, etc.).
- Strong manufacturing background with a proven track record in supporting FMEA, NCMRs, CAPAs, and validation activities.
This is a challenging and rewarding opportunity for a highly motivated quality professional to contribute to the success of our organization.
