ResponsibilitiesThe
Senior Engineer, Quality Manufacturing, joining the Quality team, will be responsible for ensuring that our medical devices meet the highest quality standards throughout the manufacturing process. You will be responsible for supporting and managing quality programs, initiatives and guiding the manufacturing team through production scale up and associated quality deliverables. The primary focus will be supporting our organization in bringing new therapy to the market by developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position will collaborate with cross-functional teams, drive process improvements, and champion a culture of quality excellence.
Key Responsibilities- Provide on-the-floor quality engineering support to production teams, ensuring real-time issue resolution.
- Develop, review, and approve inspection and test plans, sampling methods, and control plans.
- Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.
- Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
- Regulatory Compliance: Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.
- Supplier Collaboration: Work closely with suppliers to assess and improve the quality of incoming components and materials, fostering strong supplier relationships.
- Root Cause Analysis: Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions.
- Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP).
- Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices.
- Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.
- Product Testing: Support and coordinate product testing, equipment qualifications, validation and verification processes to ensure required specifications are met.
- Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.
- Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.
QualificationsRequired Experience- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related Engineering field.
- 5+ years in medical device production development
- Previous experience working in a cleanroom environment is highly preferred
- Preferred certifications: ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt.
- Strong engineering and quality background with basic knowledge of statistics/use of Minitab.
- Strong communication skills.
- Ability to make independent decisions (proactive, detail-oriented, and solution-driven)
- Fluent in English
- Light office work and telecommuting capability.
- Available to travel 20% of the time, as required domestic and international
- Must be able to lift and carry up to 50 lbs.
Preferred Qualifications 1Pay / Compensation
The expected pre-tax pay rate for this position is $94,600 - $127,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
