Regional Lead Quality Engineer

Biopharma Careers; Waltham (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

CSL Behring seeks a Regional Lead Quality Engineer for CP/MD to ensure development activities adhere to a 21 CFR Part 4 compliant QMS across FDA/EU MDR, ISO and related standards. You will guide CP/MD staff and collaborate with global manufacturing sites to achieve quality objectives.

The role oversees site quality systems, drives design controls, risk management (FMEA), vendor audits, and continuous process improvements, with periodic domestic and international travel.

Qualifications

• Requires knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, applicable FDA guidance and QMS applications.
• Minimum 2 years practical experience in medical devices R&D quality: design controls, NPD lifecycle, risk management (FMEA), V&V, usability studies, DHFs, design transfer.

Responsibilities

• Provide clear Quality guidance to assigned CP/MD development projects and ensure design development meets FDA/EU MDR and global regulatory requirements.
• Ensure external medical device development and manufacturing partners meet CSL standards; participate in audits and review quality/development agreements.

Skills

Regulatory compliance

Quality engineering

Design controls

Risk analysis

Vendor management

Communication

Collaboration

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Job description

The Regional Lead Quality Engineer CP/MD 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 escape 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.

Experience

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.

Competencies

• 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.
• A ble 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.

Travel Requirements

This role requires periodic domestic and international travel.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .