Sr. Quality Assurance Specialist

Precision One Medical; Oceanside (CA); Sur place; USD 75 000 - 117 000; Plein temps

Résumé du poste

Precision One Medical, Inc. is seeking a Sr. Quality Assurance Specialist in Oceanside, CA. The role provides regulatory and compliance leadership for manufacturing operations, quality systems, and regulatory initiatives.

You will collaborate with cross-functional teams to support change management, audit readiness, and continuous improvement while ensuring compliance with ISO13485 and FDA requirements.

Qualifications

• ISO13485 and 21 CFR Part 820/11 knowledge.
• Quality System Regulations ISO 14971 knowledge.
• Ability to adapt to change.
• Independent judgment and discretion.
• Strong written and verbal communication.
• Highly detail-oriented.
• Effective communicator across all levels.
• Computer literacy with standard software.

Responsabilités

• Adhere to the Quality Management System and regulatory requirements.
• Support implementation and improvement of QMS and regulatory processes.
• Oversee MRB, CAPA, supplier control programs.
• Maintain and facilitate the audit program and audit readiness.
• Provide ongoing status updates to senior management.
• Interface and collaborate with other departments and stakeholders.
• Identify opportunities for continuous improvement in regulatory compliance.
• Lead development, maintenance, and review of quality system procedures.

Connaissances

ISO13485 knowledge

21 CFR Part 820/11 knowledge

Regulatory compliance

Strong communication

Detail-oriented

Independent judgment

Team collaboration

Formation

Bachelor’s degree

Master’s degree

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr. Quality Assurance Specialist

INDIRECT - QUALITY Full Time Technical Oceanside, CA, US

Salary Range: $74,716.00 To $116,744.00 Annually

SUMMARY

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.

ESSENTIAL DUTIES AND 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.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• 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.

SUPERVISORY RESPONSIBILITIES

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

EDUCATION AND/OR EXPERIENCE

• Bachelor’s degree with 5+ years of experience*
• Master’s degree with 2+ years of experience*

(*or an equivalent combination of education/experience)

CERTIFICATES, LICENSES, REGISTRATIONS

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

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The work environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. The work environment also includes a typical office setting.