Sr. Quality Engineer

Workila; Fort Lauderdale (FL); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Relocation allowance up to $10,000

Performance bonus up to $5,000

Job summary

Workila is seeking a Sr. Quality Engineer in Fort Lauderdale, Florida, to ensure compliance with FDA QSR/cGMP and ISO 13485 standards. The candidate will work cross-functionally to resolve quality issues and support CAPA investigations while leading continuous improvement initiatives. The ideal candidate has a Bachelor's degree in Engineering or Science, with at least 3 years in quality engineering and 1 year in the medical device industry.

The role offers a relocation allowance, a salary range of $60,000 to $75,000, and a performance bonus potential of up to $5,000.

Qualifications

• Bachelor's degree or higher in engineering or science.
• 3+ years of experience in quality engineering.
• 1+ year experience in the medical device industry.

Responsibilities

• Work with teams to resolve quality problems.
• Lead resolution of quality issues and support CAPA investigations.
• Participate in continuous improvement activities.
• Develop and review inspection plans and product drawings.

Skills

Quality engineering experience

FDA QSR/cGMP compliance

Knowledge of GD&T and Solidworks

Root cause analysis

Experience with Critical to Quality Attributes

Education

Bachelor's degree in Engineering/Science

Tools

CMM

Job description

Job Description

The Sr. Quality Engineer will ensure a high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.

MUST-HAVES

• Bachelor's degree or higher (engineering/science)
• 3+ years quality engineering with 1+ year Med device industry
• Know GD&T, Solidworks (read drawings), root cause analysis and CAPA
• Can move NC from beginning to end, can come up with solutions
• Experience with Critical to Quality Attributes (CTQ) - tolerances on drawings

NICE-TO-HAVES

• Gage R&R, CMM (Coordinate Measurement Machine)
• Understanding of measurement methods

Responsibilities

• Work closely with internal departments (Operations, Advanced Operations, R&D, and Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.).
• Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc. Lead and/or support CAPA investigations and related corrective and preventive actions.
• Lead continuous improvement activities such as Quality Circles, Process Capability.
• Support Lean environment and re-work/scrap reduction.
• Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products.
• Participate on project teams with internal departments to support product and/or process design and development activities.
• Develop, review and improve inspection plans, routers and product drawings.
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Interface with suppliers for new processes, quality issues and process improvements for assigned projects.
• Support product transfers to other plants/facilities.
• Lead or participate in implementation of Process Management activities (pFMEA and control plans) within assigned client groups.
• Review/approve product and/or process change control documentation and specifications.
• Participate in continuous (breakthrough) improvement activity and process re-engineering projects.

More Information

• Relocation allowance up to $10,000
• Salary range: $60,000 – $75,000
• Performance bonus: $0 – $5,000