My client, a global Medical Device company, is seeking a Senior Quality Engineer to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams.
The role is an initial 12 month contract with a company that has an excellent track record of extending and converting contracts in order to retain top talent.
Please find the qualifications and requirements below.
If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV.
Position: Senior Quality Engineer
Location: Jacksonville, FL (onsite)
Duration: 12 month contract-W2 (NO C2C)
QUALITY ENGINEER MAIN JOB DUTIES/RESPONSIBILITIES
- Participates in Business Team operations to approve testing of all new product designs, design test parameters for R&D, Operations and QA, conduct reliability assessments, evaluates and approves ECN changes for existing products, monitor design developments for maintaining quality compliance and assists in software engineering, testing, and validation.
- Partners with Mfg. Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
- Participates in new product development, and establish quality and reliability expectancy of the finished product.
- Identifies, applies, and updates engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling.
- Investigates and reports on corrective actions effectiveness and timeliness. Assists audits of finished products, final inspections, returned and serviced products.
- Establishes and conducts a Failure Analysis Process to ensure Field Returns and Internal Product Failures are investigated to determine the root cause of the product deficiency.
- Minimal travel up to 20%.
- Performs other duties as assigned.
- Complies with the site Quality System.
QUALITY ENGINEER JOB EXPERIENCE
- Minimum of 3-5 years of experience with a Bachelor's degree in engineering OR one to two years with a Master's degree in engineering.
- Two to five years Quality Engineering or equivalent experience.
- Experience in medical device design and application of test standards.
- Minimum of two years industry experience, preferably in the medical device manufacturing industry.
- Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards.
- Experience in application of statistical methods.
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
- If Bachelors or Masters Degree is not in engineering an applicable professional certification is required.
QUALITY ENGINEER SKILLS
- Complete understanding and wide application of technical principles, theories, and concepts in the field.
- General knowledge of other related disciplines.
- Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
- Good oral and written communication skills.
- Cross-functionally and an effective team player.
- Excellent presentation skills.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Working knowledge of appropriate industry standards.
- Experience in application statistical methods to design reliability and process capability.
- Must be able to work in a team environment and exert influence without alienating others.
- Working knowledge of statistical analysis/software experience preferred.
- Proficiency in Microsoft Project.