Sr. Quality Assurance Specialist

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