Job Title: Quality Inspector III

Department: QUALITY

Reports To: QA / RA MANAGER

Direct Reports: N/A

Location: Skeletal Dynamics Strategic Manufacturing Center – Bonita Springs, FL

FLSA STATUS: Non-Exempt, Full Time

Summary:

Skeletal Dynamics is a fast-growing medical device company located in Kendall, FL, that designs, and markets innovative orthopedic devices sold on a worldwide basis. We are seeking a Quality Inspector III to inspect medical device components in a production environment for our Strategic Manufacturing Center located in Bonita Springs, FL.

Job Purpose:

Supports the manufacture and distribution of products at Skeletal Dynamics Strategic Manufacturing Center – Bonita Springs, FL, while maintaining compliance with regulatory statues and ISO 13485:2016. Supports quality initiatives by performing inspections of outsourced and internal finished and semi-finished medical devices, components and raw materials to ensure that product comply with product quality plans, specifications and requirements.

Key Duties and Responsibilities:

• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Perform visual, functional, and dimensional inspections across all stages of production.
• Communicate quality or compliance concerns with urgency.
• Corrects or escalates quality or compliance concerns.
• Follows all StratMan Standard Operating Procedures.
• Other duties may be assigned to meet business needs.
• Creates Non-conforming Material Reports (NCMR).

Qualifications:

• 2-3 years experience as a Quality Inspector in a regulated industry (Medical, Aerospace, Automotive)
• High School Diploma or General Education Degree (GED) required

Knowledge and Skills:

• Working knowledge of precision measuring equipment and the application of such instruments, including but not limited to calipers, inside dimension/outside dimension (ID/OD) micrometers, depth gauges, and indicators.
• Working knowledge of geometric dimensioning and tolerancing.
• Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job, on the job training provided.
• Knowledge of basic math skills to include but not limited to adding, subtracting, multiplication, division, geometry, and algebra for the purpose of calculating material fabrication.
• Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives.
• Skilled in working independently and following through with assignments with minimal direction.
• Skilled in adapting to a changing work environment and competing demands; ability to read blueprints.
• Ability to learn and adapt to changing technology.
• Ability to deal with frequent change, delays, or unexpected events.
• Ability to use reasoning skills that minimize duplication of efforts, including but not limited to comparing, classifying, analyzing, and coordinating.
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work.
• Ability to clearly communicate and understand information in English, both orally and in writing.

Note: The above reflects the present requirements of the position. Responsibilities of the position may change without prior notice.

I acknowledge receipt of this Job Description and confirm my acceptance of responsibilities, skills and values stated.

Job Type: Full-time

Pay: $24.00 - $28.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Work Location: In person