19 часов назад
Packaging/Medical Device Quality Engineer
115 000 - 136 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Packaging/Medical Device Quality Engineer (Medical Devices and Combination Products): Representing Quality in the design, development, manufacture, and regulatory approval of medical device constituent parts and packaging with an accent on design controls, risk management, and global regulatory compliance. Focus on applying 21 CFR Part 4, FDA, EU MDR, ISO standards, and quality engineering techniques while managing vendor quality, validation, root cause analysis, and product lifecycle activities.
Location: United States; listed locations include Waltham, Massachusetts and King of Prussia, Pennsylvania
Salary: $115,000–$136,000 base salary annually, plus potential incentive compensation and equity.
Company
is a global biotherapeutics company developing and delivering therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.
What you will do
- Represent Quality on combination product, medical device, and packaging development projects.
- Ensure design development follows Design Controls and applicable FDA, EU MDR, and global regulatory requirements.
- Apply quality engineering methods including risk analysis, statistical data analysis, sampling plans, and problem-solving.
- Evaluate external medical device development and manufacturing partners through audits, quality agreements, and performance monitoring.
- Support quality system improvements, SOP and work-instruction updates, process training, and regulatory compliance activities.
- Maintain combination product quality databases, report progress and risks, and support root cause analysis.
Requirements
- Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline.
- At least 5 years of experience in quality, packaging, engineering, or manufacturing within medical devices or combination products.
- At least 2 years of practical medical device R&D Quality experience covering design controls, product development, risk management, V&V, usability studies, DHFs, and design transfer.
- Working knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FDA guidance, and compliant quality management systems.
- Strong communication, collaboration, assertiveness, planning, organization, and problem-solving skills.
Nice to have
- Experience developing drug-delivery combination products.
- Experience with embedded software, mobile or web applications, and connected health solutions.
Culture & Benefits
- Work within global teams and collaborate with multiple functions and manufacturing sites.
- Benefits information is provided through CSL’s employee well-being program.
- Inclusion and belonging are emphasized as part of the organizational culture.
- Total compensation may include incentive compensation and equity in addition to base salary.
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