Quality Manufacturing Engineer

Responsibilities

• Ensure medical devices meet highest quality standards throughout the process.
• Support the team through production scale up and associated quality deliverables.
• Develop, implement, and continuously improve quality management systems, ensuring compliance with regulations, standards, and customer requirements.
• Collaborate with cross-functional teams to help identify quality issues, drive process improvements, and champion a culture of quality excellence.
• Monitor and implement quality control measures (including verification of materials, components, and finished products) at every stage of the process, ensuring compliance with regulatory standards and internal quality requirements.
• Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize efficiency.
• Work closely with R&D engineers to ensure design control is followed.
• Prepare risk assessment documentation related to processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
• Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that processes adhere to these regulations.
• Participate in root cause analysis for quality issues and recommend / implement corrective actions.
• Aid in maintaining accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with company standards.
• Analyze process data and quality metrics to identify trends and areas for improvement.
• Support sustaining current process and lead implementation of revised QS Key Interactions.
• Report on Quality Engineering to potential stakeholders.
• Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

Qualifications

• Bachelor’s degree in mechanical engineering, Biomedical or Industrial Engineering, or other related engineering fields.
• 2+ years in medical device production or previous internship or co-op experience in quality assurance is a plus.
• Previous experience working in a clean room environment is preferred.
• Strong engineering background.
• Strong analytical and problem-solving skills.
• Strong communication skills.
• Excellent attention to detail and organizational skills.
• Ability to work collaboratively in a team environment.
• Fluent in English.

Physical Requirements

• 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.

Pay / Compensation

The expected pre-tax pay rate for this position is $68,200 - $84,700. 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.