A global manufacture and distributor of medical devices are expanding their Quality team in Rhode Island.
As the Senior Quality Engineer, you will play a crucial role in ensuring that all products are manufactured to meet the highest quality standards. You will collaborate with manufacturing, engineering, and regulatory teams to maintain compliance with ISO 13485, FDA regulations, and other relevant medical device standards. Your responsibilities will include managing the Quality Management System (QMS), overseeing cleanroom operations, leading validation initiatives, and driving continuous improvements in quality processes.
Key Responsibilities:
- Coordinate and support internal and external audits, including supplier audits and regulatory inspections.
- Support the validation and qualification of equipment, processes, and products, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Drive continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and improving overall product quality.
- Lead Corrective and Preventive Actions (CAPA) to address non-conformances and ensure timely resolution of quality events
- Prepare and review technical documentation, including protocols, validation plans, work instructions, and Standard Operating Procedures (SOPs).
- Monitor compliance with cleanroom environmental control procedures, including particle count, microbial monitoring, and gowning protocols.
- Collaborate with manufacturing and engineering teams to resolve production issues while maintaining cleanroom integrity.
- Conduct risk assessments, such as Failure Modes and Effects Analysis (FMEA), to mitigate risks in product development and manufacturing.
Requirements:
- Bachelor’s or Master’s degree biology, biomedical, biotechnology, engineering or related field
- 5+ years’ experience within the medical device industry
- In depth knowledge with medical device regulations, ISO 13485, 14791, 21 CFR 820
- Team player with the ability to make independent decisions within the framework and guidelines of the organization
- Preferred CQE, Certified Auditor ISO 13485
For further information please reach out to emily.james@skillsalliance.com or call +1 (646) 889-8093
