Sr. Quality Assurance Specialist

Precision One Medical•Oceanside, CA

6h•$74,716 - $116,744•Hybrid

About The Position

The Sr. Quality Assurance Specialist provides regulatory and compliance leadership support for manufacturing operations, quality systems, and overall regulatory compliance initiatives. The role works closely with cross-functional teams to support change management activities, audit readiness, and quality system initiatives while promoting a culture of continuous improvement and regulatory compliance.

Requirements

Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11
Proficient knowledge of Quality System Regulations ISO 14971
Must be flexible and able to adapt to change
Must be able to exercise independent judgment and discretion
Strong written and verbal communication skills
Highly detail-oriented
Communicates and works well with employees of all positions
Computer literacy with standard software applications

Nice To Haves

ASQ certification preferred (e.g., Quality Engineer, Auditor, etc.)

Responsibilities

Adhere to the Company’s Quality Management System to ensure compliance with applicable regulatory requirements.
Support the implementation, maintenance, and continuous improvement of the Quality Management System and associated regulatory compliance processes.
Provide ongoing regulatory support for general manufacturing operations, validation activities, engineering changes, etc. by evaluating risk and ensuring compliance.
Oversee the material review board (MRB) program, ensuring applicable regulatory requirements and manufacturing needs are met.
Oversee the Corrective Action & Preventative Action (CAPA) program, ensuring applicable regulatory requirements and manufacturing needs are met.
Oversee the company supplier control program, including but not limited to supplier approval, monitoring, evaluations, etc.
Maintain and facilitate the company audit program, including but not limited to internal/external requirements, audit preparation, follow-up activities, etc.
Monitor and maintain awareness of applicable regulatory requirements, industry standards, and quality system expectations that could impact the business.
Identify opportunities for continuous improvement related to regulatory compliance processes, documentation systems, and overall quality system effectiveness.
Lead the development, maintenance, and review of quality system procedures and other controlled documentation.
Support document control and change management activities to ensure controlled documentation remains accurate, compliant, and current.
Provide ongoing communication and regular status updates to senior management team.
Interface and collaborate with other departments, stakeholders, etc.
Perform special assignments as directed by supervision commensurate with experience.
Promote and maintain a safe work environment by following all company safety policies, procedures, and work instructions, and by promptly reporting unsafe conditions, incidents, or concerns to supervision.
Perform other duties as assigned.