Top 38 Senior quality engineer Jobs in Alachua Fl

Senior Quality Engineer, Validation
Advita Ortho —Gainesville, FL
- Full-time
- Research
- Master's degree
- Bachelor's degree
Quick Apply
5d
Quality Systems Engineer, Senior
Advita Ortho —Gainesville, FL
- Full-time
- Engineering
- Master's degree
- Senior level
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5d
Sr. Quality Engineer
Evergen —Alachua, FL
- $90,000 - $115,000 a year
- Full-time
- Office
- Bachelor's degree
- Senior level
- Paid parental leave
- Paid holidays
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Test Engineer - Fluids | New Glenn (Mid to Senior | D and 3rd Shift)
Blue Origin —Florida
- Background check
- Management
- Schematics
- Paid parental leave
- Paid holidays
Senior/Chief Engineer
Metric Engineering —Florida
- $90 - $120 an hour
- Part-time
- Remote
- Quality control
- Mentoring
- Senior level
Lunar Lander Production Manufacturing Engineer (All levels, All shifts)
Blue Origin —Florida
- Extended hours
- Background check
- Microsoft Outlook
- Word processing
- Paid parental leave
- Paid holidays
Manufacturing Quality Engineer
Sandvik —Alachua, FL
- Full-time
- Mid-level
- 3 years
- Analysis skills
Associate Director: QA Automation
Infotech —Gainesville, FL
- Remote
- 6 years
- System design
- Java
- Paid holidays
- Health insurance
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7d
MSAT Engineer, Upstream
Ascend Advanced Therapies FL, Inc. —Alachua, FL
- Full-time
- Bachelor of Science
- Mid-level
- Master's degree
- Health savings account
- Health insurance
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Regional Environmental Manager
Barge Design Solutions —Gainesville, FL
- Background check
- Clean driving record
- Up to 50% travel
Associate Engineer
Water & Air Research —Gainesville, FL
- Google Workspace
- Clean driving record
- Analysis skills
8d
Senior Pavement Research Engineer
University of North Florida —Gainesville, FL
- $110,000 - $120,000 a year
- Full-time
- Background check
- Office
- Master's degree
Environmental Lead, Remediation
WGI —Gainesville, FL
- Full-time
- Bachelor of Science
- 11+ years
- Office
- Health savings account
- Health insurance
Senior Project Engineer-Construction Engineering and Inspection
NV5 —Alachua, FL
- Full-time
- Construction site
- Engineering
- 8 years
- Health insurance
- Dental insurance
Office Manager/Senior Water Resources Engineer
Dewberry —Gainesville, FL
- Full-time
- Background check
- Office
- Team management
Quick Apply
Staff Asphalt Research Engineer
University of North Florida —Gainesville, FL
- $90,000 - $100,000 a year
- Full-time
- Background check
- Mid-level
- Office
Senior Engineer - Civil Engineering
Jones Edmunds and Associates —Alachua, FL
- Full-time
- Hybrid work
- Management
- Construction site
- Bachelor of Science
- Paid holidays
- Disability insurance
Quick Apply
Water / Wastewater Supervising Engineer
Gainesville Regional Utilities —Gainesville, FL
- $111,935.25 - $167,902.36 a year
- Full-time
- Computer literacy
- Bachelor of Science
- Engineering
Military Service - U.S. Navy, Nuclear Engineer
U.S. Navy —United States
- $98,500 - $118,000 a year
- Full-time
- Background check
- Engineering
- Office
- Loan repayment program
- Health insurance
Senior Electrical Commissioning Engineer (Data Centers)
CAI —United States
- $91,300 - $107,300 a year
- Full-time
- Hybrid work
- Microsoft Word
- Construction site
- Customer service
- Disability insurance
- Health insurance
Quick Apply

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senior quality engineer jobs near alachua fl

Senior Quality Engineer, Validation

Advita Ortho
Gainesville, FL

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Job Details

Full-time
5 days ago

Qualifications

Statistics
Project development phase management
Quality control statistical data analysis
Research
Statistical analysis
Bachelor's degree
Managing projects
Productivity software
Cross-functional collaboration
Technical Proficiency
Cross-functional communication

Full Job Description

Description

This position offers flexibility to align with the candidate's experience level and can be structure as a Senior Validation Engineer role for those with advanced expertise.

The Validation Engineer provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Validation Engineer is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation/verification (V&V).

Key Responsibilities

Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.
Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies.
Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements.
Use statistical techniques, as necessary, to properly design and execute V&V activities.
Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.
Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings.
Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards.
Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes.
Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation.
Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase.
Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices).
Participate in the review and qualification of external supply chain V&V activities.
Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions.
Define and lead third party, customer and regulatory audits as they pertain to validations.

Skills Knowledge and Expertise

Education:

Bachelor’s Degree from an accredited institution required; Master’s Degree preferred

Experience:

Advanced level of technical software proficiency
Excellent Quality System knowledge required
Strong time management and project management skills are necessary.
Experience writing IQ/OQ/PQ V&V protocols.
Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.
General understanding of sterilization and related analytical testing is a plus.
Must be able to work independently and in a team environment.

Functional/Technical Knowledge, Skills and Abilities Required:

Statistical expertise in areas such as process capability, process assurance and sampling
Expertise in Microsoft Office products
Ability to work effectively in a team environment
ASQ Certifications preferred
Advanced level of technical software proficiency
Working knowledge of statistical analysis and sampling plans.
Excellent communication (written and verbal) skills.
Excellent organization skills.

About Advita Ortho

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Refine Your Search

senior quality engineer jobs in alachua fl

Senior Quality Engineer, Validation

Quality Systems Engineer, Senior

Sr. Quality Engineer

Test Engineer - Fluids | New Glenn (Mid to Senior | D and 3rd Shift)

Senior/Chief Engineer

Lunar Lander Production Manufacturing Engineer (All levels, All shifts)

Manufacturing Quality Engineer

Associate Director: QA Automation

MSAT Engineer, Upstream

Regional Environmental Manager

Associate Engineer

Senior Pavement Research Engineer

Environmental Lead, Remediation

Senior Project Engineer-Construction Engineering and Inspection

Office Manager/Senior Water Resources Engineer

Staff Asphalt Research Engineer

Senior Engineer - Civil Engineering

Water / Wastewater Supervising Engineer

Military Service - U.S. Navy, Nuclear Engineer

Senior Electrical Commissioning Engineer (Data Centers)

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