Top 10 Quality engineer medical device Jobs in Saint Augustine, Fl

Quality Engineer
Treace —Ponte Vedra, FL
- Full-time
- Engineering
- Mid-level
- Assembly
Quick Apply
12d
Chemical Process Engineer
Alleima —Palm Coast, FL
- Full-time
- 5 years
- Engineering
- Analysis skills
- Paid holidays
- Health insurance
Principal Research & Development (R&D) Engineer
Treace —Ponte Vedra, FL
- Full-time
- Microsoft Excel
- 5 years
- Mentoring
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Senior Product Development Engineer
Treace —Ponte Vedra, FL
- Weekends as needed
- Travel
- Manufacturing
- Senior level
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Product Design Engineer II
Amphenol CIT —Saint Augustine, FL
- Microsoft Outlook
- 5 years
- Bachelor of Science
R&D Engineer
Amphenol CIT —Saint Augustine, FL
- Engineering
- English
- Ability to lift 50 pounds
Extrusion Engineer
Amphenol CIT —Saint Augustine, FL
- $100 a day
- Ability to walk for extended periods
- Ability to lift 50 pounds
- Travel
7d

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Quality Engineer
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Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user).
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quality engineer medical device jobs near saint augustine, fl

Quality Engineer

Treace
Ponte Vedra, FL

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Job Details

Full-time
12 days ago

Qualifications

Developing medical devices
Medical device manufacturing facility experience
Biomedical regulatory compliance
Cross-functional communication
FDA regulations

Full Job Description

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY:

The Quality Engineer (QE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement. This position primarily will support in-house manufacturing operations.

PRIMARY DUTIES AND RESPONSIBILITIES:

Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
Evaluates product changes and directs appropriate disposition of product through the company’s change control system
Assemble non-sterile product into kits for final release into the field
Participate in setup, qualification, calibration, and maintenance of manufacturing and inspection equipment
Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product
Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user)
Responsible for creating and maintaining process risk management files to meet FDA and ISO standards
Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications
Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
Assists in inspection of work-in-progress, finished parts and assemblies, kits and completion of associated paperwork for final release of product
Assists in reviewing patient-specific instrumentation designs
Participates in projects and help drive and build a Continuous Improvement and Lean culture across the organization

Qualifications

MINIMUM REQUIREMENTS:

Education and Experience: Bachelor's degree in Engineering, Science, Technology or a related discipline with 3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.

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Refine Your Search

quality engineer medical device jobs in saint augustine, fl

Quality Engineer

Chemical Process Engineer

Principal Research & Development (R&D) Engineer

Senior Product Development Engineer

Product Design Engineer II

R&D Engineer

Extrusion Engineer

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