Job Description
Job Description
ob description
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 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 complies with product quality plans, specifications and requirements.
Key Duties and Responsibilities:
1. Ensure compliance to federal and state laws, as well as company standards and specifications.
2. Perform visual, functional, and dimensional inspections across all stages of production.
3. Communicate quality or compliance concerns with urgency.
4. Corrects or escalates quality or compliance concerns.
5. Follows all Standard Operating Procedures.
6. Other duties may be assigned to meet business needs.
7. Creates Non-conforming Material Reports (NCMR).
The jobholder should possess the skills set out below to meet the requirements of the role:
Qualifications:
- High School Diploma or General Education Degree (GED) required.
- 2 years experience within a regulated industry, i.e. medial, aerospace, or automotive.
- Ability to run without supervision, Coordinate Measuring Machine (CMM) or Vision Systems.
- Experience in the orthopedic or implantable medical device industry.
- ASQ Certification, CQI/CQT is a plus.
Knowledge and Skills:
- Thorough 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 and ability to teach others.
- Thorough knowledge of geometric dimensioning and tolerancing.
- Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job.
- 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 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
- Ability to create and compile Device History Records for review.
- Ability to evaluate Supplier Documentation ensuring that it meets StratMan requirements for Current Good Documentation Practices (cGDP).
- Ability to run Zeiss CMM utilizing Calypso Software.
Note: The above reflects the present requirements of the position. Responsibilities of the position may change without prior notice.
Job Type: Full-time
Pay: $20.00 - $23.85 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Experience:
- Medical Device: 2 years (Required)
Language:
- English (Required)
Shift availability:
- Day Shift (Preferred)
Ability to Commute:
- Bonita Springs, FL 34135 (Required)
Ability to Relocate:
- Bonita Springs, FL 34135: Relocate before starting work (Required)
Work Location: In person