Quality Director (Contract) Resume Raleigh, NC - Hire IT People

SUMMARY

Approximately 15 years in the medical device field as an Engineer and Manager in Quality and Regulatory roles. I have focused on both production and product development, and I have worked in both FT and contract/consulting positions. I have experience in both small and large companies and am looking for a new opportunity in the industry. I am open to either contract roles or the right direct hire role.

PROFESSIONAL EXPERIENCE

Confidential, Raleigh, NC

Quality Director (Contract)

Responsibilities:

Confidential is a company in clinical trials for a Class 3 iVAS device. In this role I am creating their Quality System and acting as Quality authority for the Product Development Program, and scale - up to launch.

Confidential, Ann Arbor, MI

Director QA/RA

Responsibilities:

Micro-Tech is an importer and distributor of a large foreign parent company’s class 1 and 2 endoscopic products. In this role I established their QMS and support it weekly as Head of QA/RA. This includes complaint activities, management review, NPI, etc.

Confidential, Naples, FL

Quality Engineering Manager

Responsibilities:

Arthrex is a global leader in orthopedic implants and sports injury repair. In this role I oversaw the Quality Engineering activities for their 3 southwest Florida Manufacturing and Distribution facilities.

Confidential, Ann Arbor, MI

Quality Systems and Regulatory Affairs Director

Responsibilities:

Tangent is a small (<25 employees) startup company with a portfolio of proprietary Peripheral IV Catheters. I came on board when no quality system existed and the design was in its infancy. I guided many aspects of the project through design, pilot launch, offshore production scale-up, regulatory approval, and commercial release (May 2013). Until the company’s acquisition in 2016, I led all Quality and Regulatory functions in supporting production, customers, and regulatory bodies.

Confidential, Ann Arbor, MI

Engineering Manager, Production Supervisor, Engineer

Responsibilities:

Terumo is a multinational corporation with an array of Class 1-3 medical devices. Confidential is responsible for the design and manufacture of medical devices supporting open heart surgery (both large capital equipment and disposable products). I began as an engineer supporting production and quality, transitioned to a leadership role in production, led a production relocation project, and ended up with a leadership role in product development.

Confidential

Quality Manager, Engineer

Responsibilities:

Established and Participated In all phases of PDP:
Key Member in Design Inputs/Outputs, Verification & Validation, MFG Scale-Up, PMS/PMCF.
Submitter and active in 510(k) submissions, FDA & CPB correspondences.
Have successfully led projects to achieve CE Mark, and approval in dozens of other countries.
Lead for FMEA/PHA/Other Risk Management Tools and their effective implementation and use.

Production Support

Quality Manager, Mfg/Process Engineer, Production Supervisor

Responsibilities:

NCRs: Established Systems For, Led Large Facilities in, Dispositioned & Executed Hundreds of.
Validations (Process, Software, Design): Written/Executed Hundreds of protocols, plans, reports.
Hands-On with several ERP/MRB/Planning resources (JDE, Expandable, Quickbooks, SAP)
Frequent travel to and work with foreign companies.
Champion of visual factories and distribution of knowledge for good decision making.
Good Knowledge of Controlled Environments and EO Sterilization Processes.
Vast experience in Fixture Creation, Inspection Setup, NPI support, Test Method Validation.

Confidential

Sr. Engineer, QE Manager, QA Manager, Dir QA/RA

Responsibilities:

12+ years of direct reports (hiring/letting go/assessing performance/coaching/personality conflicts/etc.):
Groups of 30+ Hourly Production Associates