Quality Mfg Engineer, Selution - Cordis

MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you.  Join us, and let’s improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

The Quality Manufacturing Engineer (QME) joining our Quality team, will be responsible for ensuring that our medical devices meet the highest quality standards throughout the manufacturing process.  The QME will be responsible for supporting the manufacturing team through production scale up and associated quality deliverables. The primary focus will be ensuring that our manufacturing processes and products meet established quality standards through developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position will collaborate with cross-functional teams to help identify quality issues, drive process improvements, and champion a culture of quality excellence.

Key Accountabilities

Quality Control: Monitor and implement quality control measures (including verification of materials, components, and finished products) at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements.

Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.

Risk Assessment: Prepare risk assessment documentation 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: Participate in root cause analysis for quality issues and recommend / implement corrective actions.

Documentation: Assist in maintaining accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with company standards.

Product Testing: Perform product testing as required to ensure products meet required specifications.

Data Analysis: Analyze manufacturing process data and quality metrics to identify trends and areas for improvement.

Strategic Impact

Quality support to sustaining current manufacturing process.

Quality lead on support and implementation of revised QS

Key Interactions

Reports into Quality Engineering.

Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

• Bachelor’s degree in mechanical engineering, Biomedical or Industrial Engineering, or other related engineering field.
• 1-2 years in medical device production or previous internship or co-op experience in quality assurance or manufacturing is a plus.
• Previous experience working in a clean room environment [preferred]

Competencies & Skills

• 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

Pay / Compensation
The expected pre-tax pay rate for this position is $63,800 - $79,750

Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.

Benefits: Med Alliance offers a competitive benefits package including:  

• 401(k)
• Medical, Dental and Vision Insurance
• Life insurance
• Paid time off