Quality Engineer - Emerging Medical Device Company With Impressive Management Team! (orlando, Fl)
Hudson (Orlando, Florida)

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This is a great opportunity to join a start-up medical device firm that is on the forefront of emerging spinal/orthopedic implant technology. The company is publicy traded and backed by significant venture capital. The management team has an impressive track record of developing new medical device products and marketing them successfully, creating large established businesses. The company recently received FDA approval and is in clinical trials for a unique spinal implant device that they plan to market. They also have other products in approval mode.

The Quality Assurance Engineer is responsible for assuring the quality and integrity of medical devices through testing, investigation and analysis of results. He or she will be responsible for assurance matters and will work closely with senior management.  The quality engineer will have the opportunity to:  

Support quality improvement projects throughout the life cycle of the company’s products Lead and assist in Root Cause Analysis/Corrective and Preventive Action (CAPA) projects Utilize statistical analysis and trending (e.g. rejection rate/complaint rate monitoring) to implement process improvements Conduct system and process audits Perform validations (e.g. IQ/OQ/PQ) Create and review Quality System documentation Provide leadership and support in all quality engineering matters

The following experience is required for the Quality Engineering role:

Bachelor’s Degree (B.S.) from a four-year university in an engineering discipline (Biomedical, Mechanical) 3+ years medical device experience Strong working knowledge of FDA/QSR, ISO 13485:2003, Quality Engineering principles, and quality tools and methods

ASQ Certification (e.g. CQE, CMQ/OE, CSSGB, CSSBB) preferable

Salary Range is $60K - $70K plus up to 5% bonus but client may consider more senior candidates for a managerial role (at a higher salary rate).  Fully vested 401K plan (upon start date) with 100% match up to 6%. Comprehensive medical and dental plan.  Stock option eligibility.

For immediate consideration, please email your resume to Monica Levine at monica.levine@hudson.com