Regulated Manufacturing Quality Specialist
1 day ago
The Quality System Specialist role plays a crucial part in maintaining and improving our company's Quality Management System (QMS).
This position is responsible for supporting and performing activities associated with the QMS, including but not limited to change control, CAPA, audit, and management review meeting.
The specialist will collaborate with internal stakeholders such as Manufacturing Engineering, Quality Control, and Value Engineering, as well as external stakeholders like R&D and Regulatory Affairs, to assess change impact and ensure alignment.
Some of the key responsibilities include managing the change request process, supporting and co-managing the Corrective and Preventive Action (CAPA) process, preparing materials for periodic management review meetings, and providing active support during internal audits and external audits/inspections.
Required Skills and Qualifications:- Bachelor's degree or equivalent in a related life science/technical discipline or equivalent preferred.
- ISO 13485:2016 Lead Auditor certified preferred
- At least 2+ years' experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Experience with QMS Databases (i.e., Veeva, SAP)
- Understanding of GMP and quality system standards as they apply to products manufactured by us.
- Strong communication and coordination skills across cross-functional and global teams.
- Decision making, time management, organization, and computer skills.
- Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes.
- Detail-oriented and ability to multitask.
We offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities, and more. Our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce.
Equal Employment Opportunity:We are an Equal Employment Opportunity/Affirmative Action employer and welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
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