QA Technician

Socket.dev; California (MO); On-site; USD 70,000 - 95,000; Full time

Job summary

Socket.dev is seeking a Quality Documentation Specialist to ensure ISO 13485 and 21 CFR Part 820/11 compliance. You will establish and maintain the document control system, process changes, and ensure controlled documentation is reviewed and stored properly.

Collaborate with engineering and production to keep documentation up to date, support MRB and training programs, and drive continuous improvement. A Bachelor’s degree and 3+ years in medical device manufacturing are required.

Qualifications

• Bachelor’s degree required; 3+ years in medical device manufacturing.
• Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11.
• Strong documentation skills and attention to detail.

Responsibilities

• Establish, document, conduct, and maintain the document control system.
• Manage Change Control Board (CCB) and documentation processing.
• Inspect devices and maintain device history records.
• Coordinate with engineering and other departments to ensure timely documentation.
• Provide ongoing communication and status updates to leadership.

Skills

ISO 13485

21 CFR Part 820/11

GD&T blueprint reading

Precision measurement tools

Strong written/verbal communication

Detail oriented

Independent judgment

External stakeholder collaboration

Education

Bachelor’s degree in a related field

3+ years in medical device manufacturing

Tools

MS Office

Quality management software

Job description

ESSENTIALDUTIESANDRESPONSIBILITIES

• Adhere to the Company’s Quality Management System to ensure compliance with applicable regulatory requirements.
• Establish, document, conduct, and maintain the company document control system, including but not limited to document approval, distribution, changes, and storage/retrieval
• Ensure all controlled documentation is reviewed and completed per established procedures and requirements
• Manage the Change Control Board (CCB) and any tasks associated with the processing of controlled documentation
• Manage the preparation, processing, and distribution of quality manufacturing documentation
• Manage and maintain the storage system for all hardcopy and electronic records, including the organization and numbering of quality system documentation
• Inspect device components and finished devices per established inspection procedures
• Maintain and create new inspection plans as required
• Review and maintain completed device history records
• Support the nonconforming materials system, including material review board (MRB) efforts
• Coordinate activities with engineering and other departments to ensure production schedules are met by ensuring appropriate documentation is complete and ready
• Manage the company training program, ensuring that applicable requirements are met in a timely manner
• Identify and drive continuous improvement opportunities related to document control processes
• Maintain the integrity of all applicable quality documents and records
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, outside vendors, stakeholders, etc.
• Perform other duties as required

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
• Basic blueprint reading (GD&T)
• Basic skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.)
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Highly detail-oriented
• Must be able to exercise independent judgment and discretion
• Communicates and works well with employees of all positions
• Project collaboration experience involving external stakeholders
• Computer literacy with standard software applications

EDUCATION AND/OR EXPERIENCE

• Bachelor’s degree required
• 3+ years of experience in a medical device manufacturing environment

CERTIFICATES, LICENSES, REGISTRATIONS

• N/A

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation 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 utilize 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 = RarelyLess than 1 hour per week

O = Occasional1% to 33% of time

F = Frequent34% to 66% of time

C = Constantover 66% of time

Activity

Frequency

Activity

Frequency

Activity

Frequency

Activity

Frequency

Activity

Frequency

Under 10 lbs

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☒

☐

☐

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Reach over shoulder

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☐

☒

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11-20 lbs

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☐

☒

☐

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Reach over head

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☐

☒

☐

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21-50 lb

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☒

☐

☐

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Reach outward

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☐

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51-100 lbs

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Climb

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Over 100 lbs

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Crawl

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Pushing/Pulling

N

R

O

F

C

Kneel

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Under 10 lbs

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Squat

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11-20 lbs

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Sit

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21-50 lbs

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Walk-Normal Surfaces

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☐

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51-100 lbs

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☐

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Walk-Uneven Surfaces

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☒

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Over 100 lbs

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☐

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Walk-Slippery Surfaces

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Other

N

R

O

F

C

Stand

☐

☐

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Keyboard/Ten Key

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Bend

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Fingering (fine dexterity)

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Driving

N

R

O

F

C

Handling (grasping, holding)

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☐

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Automatic Trans

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Repetitive Motion - Hands

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Standard Trans

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Repetitive Motion - Feet

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