Position Responsibilities may include:

· Develop working knowledge of the QMS and provide guidance to manufacturing and support teams appropriate to role level.

· Review batch records and perform product release activities.

· Review cGMP documentation and manage document control and archival processes.

· Provide QA on-the-floor support during manufacturing operations.

· Support investigation and resolution of deviations and nonconformances affecting in-process and finished products.

· Support internal and external audits, including preparation and follow-up activities.

· Initiate and support change control activities in collaboration with departmental Subject Matter Experts (SMEs).

· Perform risk assessments, document investigations, and author or support corrective and preventive tasks.

· Perform incoming inspection and release of raw materials and consumables.

· Maintain compliance with ISO 13485:2016 and applicable FDA Quality System Regulations (21 CFR Part 820).

· Support continuous improvement initiatives within the Quality function.

· Support the strategic priorities of the Company and Quality function.

· Assist with any additional Quality-delegated tasks.

Skills

· Strong interpersonal, written, and communication skills.

· Ability to follow written instructions and perform tasks with direct or minimal supervision.

· Effectively works independently, as well as in a team environment.

· Detail-oriented and ability to multitask.

· Microsoft Office (i.e., Word/Excel/ PowerPoint) Proficient.

· NetSuite, SAP, or similar ERP programs highly desirable.

· Ability to critically analyze datasets, draw meaningful conclusions, and identify next questions or data gaps.

· Ability to synthesize complex or abstract concepts into structured, actionable insights.

· Resourceful problem-solver with the ability to independently identify solutions and leverage available tools and information effectively.

· Strong desire to learn, grow, and continuously expand technical and professional skillsets.

QA Specialist I

· Bachelor's degree in a related life science or technical discipline.

· 1-3 years of experience in a regulated manufacturing, medical device, biotechnology, or pharmaceutical environment (QC or manufacturing experience acceptable).

QA Specialist II

· Bachelor's degree in a related life science or technical discipline.

· 3-5 years of progressive experience in a regulated manufacturing, medical device, biotechnology, or pharmaceutical environment.

· Demonstrated experience independently managing deviations, CAPAs, or change controls.