Regional Lead Quality Engineer

The Regional Lead Quality Engineer CP/MD is responsible for leading a regional team comprised 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).

This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system in accordance with FDA / MDR regulations, ISO, and other industry standards with the emphasis on Design Control process. This role is involved in quality related activities throughout the entire product lifecycle from product concept, licensure, launch, and post market support. The Regional Lead Quality Engineer CP/MD will provide guidance and oversight to CP/MD local staff and collaborate with the multiple global functions and manufacturing sites to achieve the primary objectives.

This role assures product development and site level execution of the local CP/MD Quality System for combination products to govern quality related business processes throughout the entire combination product lifecycle, with emphasis on the new product development activities.

Reports To: Combination Product and Medical Device Head

Direct Reports: N/A

Responsibilities and Accountabilities:

1. 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.

2. 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.

3. Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.

4. 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.

5. Stay abreast of changing regulatory requirements for medical devices and combination products.

6. Maintain systems / databases related to the combination products, as assigned. Examples may include Applicable Standards List, vendor certificate database, test method validation log.

7. Uses six sigma problem solving to bring solutions and resolve issues quickly.

Education

• Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.

• Requires a 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.

• The Medical Device and Packaging QA Staff (Advisor) should have a 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.
• The Medical Device and Packaging QA Staff (Advisor) should have 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.
• Effective communication and collaboration skills.
• Able to influence stakeholders and demonstrates assertiveness.
• This role requires 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.

• This role requires periodic domestic and international travel.