Regional Lead Quality Engineer

About the role

The Regional Lead Quality Engineer CP/MD is responsible for leading a regional team of Medical Device and Packaging QA Staff (Advisor) that supports design, development, manufacture, and regulatory approval of combination products, including medical device constituent part(s).

Responsibilities

• Provide clear Quality guidance and oversight to assigned combination product development projects. Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
• Ensure external medical device development and manufacturing partners meet the standards and criteria set by CSL. Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.
• Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.
• Assure development and implementation of the quality system compliant with 21 CFR Part 4, MDR and other global requirements. Propose and drive improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.
• Stay abreast of changing regulatory requirements for medical devices and combination products.
• Maintain systems / databases related to the combination products, as assigned.
• Uses six sigma problem solving to bring solutions and resolve issues quickly.

Requirements

• Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum of 5 years of experience as a quality, packaging, engineer or manufacturing professional in medical devices or combination products field. May consider candidates with pharmaceutical, biotech, medtech or other related background.

Qualifications

• Working knowledge and seen as subject matter expert of the medical device and combination product regulations and requirements, at a minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards and their application in a compliant QMS.
• Minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / human factor studies, DHFs, design transfer.
• Able to influence stakeholders and demonstrates assertiveness.
• Problem-solving skills to allow identifying and resolving problems in a timely manner.
• Excellent planning / organization skills to allow prioritizing work activities and using time effectively.
• Experience with developing drug-delivery combination products is strongly preferred. Experience with products that include embedded software, mobile / web apps and other connected health solutions is a plus.

Benefits

Pay: $143,000 - $169,000
Schedule: Full-time
Benefits: Health insurance, retirement plans, paid time off, and more.

Pay

$143,000 - $169,000

Schedule

Full-time

Benefits

Health insurance, retirement plans, paid time off, and more.