Mark Shewmaker Email & Phone Number

New York, Ny, Us

Quality Solutions Consultants opened the doors in late 2009 with a mission to assist small to midsize manufacturing companies with the development of a quality management system for subsequent ISO certification that would maximize output (profits) while increasing efficiency and boosting market share. QSC has taken 6 local companies through the ISO development/ certification process either for for 9001,13485, or 9100 over the last few years. QSC can assist in the creation, implementation, and certification to 9001:2015 (general manufacturing), 13485:2008 (medical devices), and 9100 (Rev D Aerospace). QSC can develop a local supplier base for companies new to the area. QSC has over 30 years of combined experience with product development for many types of medical devices to include, but not limited to: Class I surgical Instrumentation, Class II orthopedic implants to include all knee replacement components, hip replacement components, and spinal implants/cages. The list also includes Catheter based products to include cardiac, urology, PTA/PTNA, Imaging, and stent delivery catheters, as well as Class III devices to include defibulator and defibulator lead delivery tools. QSC can perform Program Management duties for projects tracking progress and securing deadlines. Areas of expertise include:Quality System Gap Analysis (ISO)ISO9001:2015, ISO13485:2015, ISO9100 (rev.D) Implementation/ Training/ Certification/ Auditing-Program Management-Medical device developmentMedical device risk management (FMEAs)Product return investigations, CAPAsSupplier Qualification (Test method development, process and component qualificationEquipment and process validations (IQ-OQ-PQ);Training to include: Blue print reading, GD&T interpretation, CMM programmingProduct inspection- FAI and in-process (lot), and finalComparator programming and Overlay developmentReverse engineering

Lead QA Engineer responsible for ensuring all design control(s) were identified relative to CFR part 21 (820.30- Design Controls) for a state-of-the-art electroporation, electro-mechanical device used in combination with a biologic that was on target to cure skin cancer in 3-5 years. Responsibilities include risk management, Identifying high risk components and setting up the supplier base to mitigate risk through robust supplier qualification activities. Duties also included championing NCR/MRB root cause analysis and corrective action(s) to resolve subsequent issue(s). Responsible for approval of all electrical and mechanical test protocols for pre-DV.

Hudson, Wi, Us

PFMEA lead for an Insulin pen, responsible for spreadsheet validation for the testing group

ISO implementation and certification to ISO 9001 and 13485. Development of class I and II spinal implants to include equipment and process validations. Managed NCR/ CAPA system to include complaint handling. Responsible for implementation and directing internal and external audit system; Duties also included those associated with being company Management Representative, responsible for all management reviews providing company performance metrics to executive staff quarterly.

Webster, Tx, Us

Responsible for entire Risk Management program for medical devices, reliability testing, field return investigation(s), and process and equipment validations.

Managed (3) internal product development teams for contract medical device development for two of the largest medical device companies in the world. Managed budgets of $2mil + for two development programs.

Naples, Florida, Us

responsible for equipment and process validations for inspection and test equipment. Responsible for optimization of CNC equipment through equipment and process validations using laser interferometer technology. Responsible for NCRs, CAPAs, product development of uni-compartmental knee (orthopedic), and was lead trainer of facility and employees for blue print reading, GD& T interpretation, and equipment programming.

Associate’S Degree, Business Management

Bachelor Of Arts - Ba, Theology/Theological Studies

Bachelor Of Fine Arts - Bfa, Theology/Theological Studies

Theology/Theological Studies

Bachelor Of Arts - Ba, Theology/Theological Studies

Bachelor Of Arts - Ba, Theology/Theological Studies