PackagingMedical Device Quality Specialist

As part of the Quality for Combination Products and Medical Devices (CP/MD QA) department the Combination Product and Medical Device and Packaging QA Associate represents Quality in global teams involved in the design development manufacture and regulatory approval of CSL combination products. These products include medical device constituent parts developed to enable convenience monitoring compliance and effective outcomes for patients.

This role ensures new product development activities for CSL combination product projects follow a 21 CFR Part 4-compliant quality system. The role serves as a subject matter expert on medical device and combination product requirements in accordance with FDA and EU MDR regulations ISO standards and industry best practices with an emphasis on the Design Controls process. The position supports quality-related activities throughout the product lifecycle from concept through industrialization and post-market support collaborating with multiple global functions and manufacturing sites.

Main Responsibilities and Accountabilities

Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and internal/external team members to ensure design and development work meets applicable FDA EU MDR and other global regulatory requirements. Ensure design teams follow the Design Controls process and use appropriate quality engineering techniques (e.g. risk analysis statistical data analysis sampling plan development). Ensure external medical device development and manufacturing partners meet CSL standards and criteria. Support vendor management activities by participating in audits; reviewing quality and/or development agreements; and monitoring vendor performance. Provide regular progress reports and escalate potential risks related to the Quality System and/or project status to Quality management and stakeholders. Assist with development and implementation of a quality system compliant with 21 CFR Part 4 MDR and other global requirements. As assigned propose improvements to existing processes; update SOPs/WIs/Forms; and develop and conduct training on modified processes. Stay abreast of changing regulatory requirements for medical devices and combination products. Maintain systems/databases related to combination products as assigned (e.g. Applicable Standards List vendor certificate database test method validation log). Conduct root cause analysis and problem-solve issues providing recommendations.

Education

• Bachelors degree in mechanical engineering biomedical engineering life sciences or a relevant discipline.

Experience

• Minimum 3 years of experience as a quality packaging engineering or manufacturing professional in the medical devices or combination products field.

• Candidates with pharmaceutical biotech MedTech or other related backgrounds may be considered.

Competencies

• Working knowledge of medical device and combination product regulations and requirements including (at 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 of practical experience in medical devices R&D Quality including design controls; new product development life cycle; requirements specifications; risk management (including FMEA); verification and validation (V&V); usability/human factors studies; DHFs; and design transfer.

• Effective communication and collaboration skills.

• Assertiveness.

• Problem-solving skills to identify and resolve issues in a timely manner.

• Planning and organization skills to prioritize work activities and use time effectively.

• Preferred: Experience developing drug-delivery combination products.

• Plus: Experience with products that include embedded software mobile/web apps and other connected health solutions.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at Benefits

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

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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 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 Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1