New

Sr. Quality Assurance Specialist

Precision One Medical

74716.00 To 116744.00 (USD) Annually

United States, California, Oceanside

3923 Oceanic Drive (Show on map)

Sep 18, 2026

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

Direct Reports: Yes N/A

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.

PHYSICAL DEMANDS

Analysis of Physical Demands N = Never R = Rarely Less than 1 hour per week O = Occasional 1% to 33% of time F = Frequent 34% to 66% of time C = Constant over 66% of time
Activity	Frequency	Activity	Frequency
Lifting/Carrying	N	R	O	F	C	Twisting/Turning	N	R	O	F	C
Under 10 lbs						Reach over shoulder
11-20 lbs						Reach over head
21-50 lb						Reach outward
51-100 lbs						Climb
Over 100 lbs						Crawl
Pushing/Pulling	N	R	O	F	C	Kneel
Under 10 lbs						Squat
11-20 lbs						Sit
21-50 lbs						Walk-Normal Surfaces
51-100 lbs						Walk-Uneven Surfaces
Over 100 lbs						Walk-Slippery Surfaces
Other	N	R	O	F	C	Stand
Keyboard/Ten Key						Bend
Fingering (fine dexterity)						Driving	N	R	O	F	C
Handling (grasping, holding)						Automatic Trans
Repetitive Motion - Hands						Standard Trans
Repetitive Motion - Feet

Monday- Thursday 5:30 am - 3:30 pm