JOSEPH EDWARD D’AMBROSIO

*** ******* ******** **.

Sarver, PA 16055

E-mail: p0rt0z@r.postjobfree.com

Cell: 1-724-***-****

PROFESSIONAL PROFILE

Fifteen years professional work experience as a Product, Process, and Supplier Quality Assurance Manager and Engineer in ISO 13485:2003, cGMP 21 CFR Part 820 (FDA Regulation), 93/42/EEC MDD (EU Regulation), SOR/98-282 CMDCAS (Health Canada Regulation) and ISO 9001:2008 manufacturing environments. Advanced Graduate Certification in Statistical Quality Control, Six Sigma Green Belt Certification, Reliability Certificate in Life Data Analysis and a Bachelor of Science in Industrial Engineering. Possess the vision necessary to develop and implement successful action plans, the experience to build and lead an effective team, and the drive and dedication to follow-through to a successful conclusion. Substantial experience with manufacturing and design quality management of FDA and MDD class IIa and IIb medical devices. Motivated, detail oriented, self-starter with a track record of successfully implementing quality management systems and leading business process improvement initiatives. Extensive experience in:

Quality Management / Planning Design Controls (NPD/Sustained) Supplier Quality Management

Hiring, Supervision and Training Reliability Budgeting / Analysis Product Realization (APQP)

Validation (Product and Process) Risk Management (ISO 14971) Auditing (Internal / External)

Problem Solving / CAPA Mgt. Process Controls Change Management

PROFESSIONAL EXPERIENCE

Risk Management and Validation Consultant

GAYMAR INDUSTRIES INCORPORATED (a subsidiary of Stryker Corporation) - Orchard Park, New York

Designer and manufacturer of Pressure Ulcer Management Product and Temperature Management Products; $100 million in annual sales. (www.gaymar.com) (December 2010 - Present)

• Conduct Risk Assessment of all Product Families / Catalog Numbers for the purpose of identifying the Risk of Harm to the patient and/or caregiver as part of due diligence in preparation for FDA audit, secondly for the purpose of providing documentation for rationalizing Medical Device Report (MDR) decisions.

Quality Assurance Manager and Validation Manager

OBERG MEDICAL (a subsidiary of Oberg Industries Inc.) - Freeport, Pennsylvania

Precision custom metal manufacturer supporting large OEM’s in the orthopedic, laparoscopic and endoscopic marketplaces with medical device implants and instrumentations; $20 million in annual sales. (www.oberg.com) (January 2010 - November 2010)

Quality Management System (QMS)

• Mentored the Executive Management Team and Medical Management Team toward the requirements of ISO 13485:2003 and 21 CFR Part; the resources required to support the new QMS (development and sustaining resources), and the cost and timing for the phases of implementation and certification.

Supplier Quality Management

• Educated and trained personnel toward cGMP/ISO “Purchasing Controls” requirements. Worked with personnel to develop an efficient Risk Based Supplier Quality Management Program in support of Supplier Compliance, Supplier Certification and Dock to Stock goals. Program phases include:

o Supplier Classifications / Risk Assessments (Phase I)

o Supplier Quality Agreement (Phase II)

o Validation (Phase III)

o Product Realization (Phase IV)

o Inspection Reduction (Phase V)

• Developed and implemented the supporting procedure(s) and completed Phases I and II of the V Phase approach. Phase III work was in-process with demonstrated evidence of progress.

• In parallel to completing Phase I, Phase II and partial Phase III, managed the development of the Approved Supplier List and the population of the supplier file quality records.

Process Validation

• Developed the Master Validation Plan (MVP) and Master Validation Reporting System (MVRS) to communicate Qualification/Validation status, priorities, and requirements.

• Educated and trained personnel toward the cGMP/ISO “Process Validation” requirements. Developed and implemented the Qualification/Validation Procedure and Risk Management Procedure.

• Developed qualification/validation templates (EIQ, EOQ, and PPQ) to support qualification/validation efforts.

• Reviewed/Approved “Special Process” pre/post qualification/validation documentation “Special Process” in the areas of Cleaning, Passivation, and Heat Treating / Tempering.

• Reviewed/Approved “Critical” manufacturing equipment pre/post validation/qualification documentation in support of Multi-Axis Vertical and Horizontal Milling, Swiss Turning, Wire/Plunger EDM.

Product Realization / Acceptance Activities

• Educated and trained personnel toward the cGMP/ISO “Product Realization / Acceptance Activities” requirements.

• Develop and implemented systems for Advanced Product Quality Planning (APQP), In-process Inspection and Final Inspection.

o A pre-production manufacturing and quality plan was developed and transcended to manufacturing and quality. Manufacturing ensured that the plans remained intact throughout production and quality ensured that the plans remained intact through final inspection and product release.

Customer Feedback

• Responsible for communicating all phases of problem solving activity / progress with the customer. Focused on a four phase communication approach. Ensured that the customers felt confident that the problem was properly identified, contained, temporary corrective actions and permanent corrective actions.

Quality Engineering Manager and Validation Manager

SIGMA LLC (a subsidiary of Baxter) - Medina, New York

Designer and manufacturer of the wireless technology “Smart” Infusion Pump; $200 million in annual sales. (www.sigmapumps.com) (June 2009 - December 2009)

• Developed the validation plan and supporting documentation (POQ and PPQ) for a $1.6 million lean manufacturing line expansion. The equipment received full (EIQ), equipment specifications were tested throughout (EOQ) conduction.

• Responsible for the design control activities and design control chronology of two new products (Pain Management Pump and Syringe Pump). Worked directly with the new project teams from planning, design inputs, design outputs and the preliminary portions of verification and validation.

• Responsible for the design validation of three significant hardware design changes and two significant software changes.

• Participated in risk analysis activities (i.e. risk plan PHA, DFMEA and PFMEA). Ensured software bug list was properly updated into risk management system.

• The corporate Statistical Techniques Procedure was cited through a FDA third party audit for inadequate statistical sample size determination. Developed and implemented a risk based corrective action, resulting in a common approach to sample size requirements for validations etc…

Quality Assurance Engineer / Supplier Quality Engineer / Reliability Engineer

GAYMAR INDUSTRIES INCORPORATED (a subsidiary of Stryker Corporation) - Orchard Park, New York

Designer and manufacturer of Pressure Ulcer Management Product and Temperature Management Products; $100 million in annual sales. (www.gaymar.com) (August 2006 - July 2009)

• New product team representative to ensure that the design controls and supporting technical documentation was properly established and documented in support of the applicable requirements (13485:2003, QSR 21 CFR Part 820, MDD 93/42/EEC and CMDCAS SOR/98-282).

• Reviewed and approved product and process qualification/validation protocols, and mentored engineering on required improvements to satisfy compliance and technical concerns.

• Provided corporate training in the areas of Problem Solving and Statistics. Successfully lead several teams through the DMAIC approach to 8D problems solving to identify root cause and implement permanent corrective action.

• Reviewed customer complaints for Medical Device Report (MDR) decision and internal complaint classification decision. Entered applicable complaints for CAPA management requirements to be imposed.

• Developed corporate reliability procedure (DFR) and led all reliability efforts for new product development and legacy products.

• Mentored statistical knowledge to engineering staff as requested (i.e. sample size determination, verification / validation testing analysis, GR&R studies, DOE studies, hypothesis testing, reliability analysis, warranty prediction models etc…)

• Ensured that the design control stages (planning, design input, design output, verification, validations and design transfer) were properly adhered and documented on three new product launches.

• Responsible for the monitoring and development of new and sustained suppliers.

• Coordinated supplier audit activity, lead internal pre-audit meetings to define purpose, scope, agenda, responsibilities, existing quality / delivery issues and open / previous CAPA activity.

• Lead the Gaymar on-site supplier audit activities, responsible for the post audit report, supplier feedback and management communication as to the audit results and the overall impression of the supplier. (Over 60 audits conducted in three years).

• Responsible for the monitoring of supplier’s performance toward quality, on-time delivery and certification objectives. Communicated directly with suppliers to ensure that quality issues were effectively resolved.

• Successfully transitioned and sustained over 300 receiving inspection part numbers into the dock to stock program.

• Internal audit team member responsible for the conduction and report generation of internal audits against the requirements of ISO 13485:2003, QSR 21 CFR Part 820, MDD 93/42/EEC and CMDCAS SOR/98-282.

Quality Assurance Engineer

PRESTOLITE LEECE-NEVILLE - Arcade, New York

Designer and manufacturer of heavy duty Alternators and Starter Motors to commercial and government markets; $120 million in annual sales. (www.prestolite.com) (June 2005 - July 2006)

Quality Assurance Manager

DIMAR MANUFACTURING - Clarence, New York

Custom sheet metal manufacturer supporting the aerospace, medical, transportation and military markets with; $15 million in annual sales. (www.dimarmfg.com) (April 2000 - June 2005)

Manufacturing Engineer / Quality Assurance Engineer

GREATBATCH - Clarence, New York

Designer and manufacturer of implantable power sources utilized in the implantable pacemaker; $500 million in annual sales. (www.greatbatch.com) (May 1994 - March 1999)

EDUCATION / CERTIFICATION

BACHELOR OF SCIENCE DEGREE, Industrial Engineering

State College of New York at Buffalo

Buffalo, New York

ADVANCED GRADUATE CERTIFICATION STATISTICAL QUALITY CONTROL

Rochester Institute of Technology (RIT)

Rochester, New York

Statistics I Statistics II

Design of Experiments (DOE) I Design of Experiments (DOE) II

Acceptance Sampling Statistical Process Control

Quality Engineering Quality Management

MINOR TECHNOLOGY EDUCATION

State College of New York at Buffalo

Buffalo, New York

SIX SIGMA GREEN BELT CERTIFICATION

State University of New York at Buffalo (UB)

Buffalo, New York

(March 2006)

TECHNICAL SKILLS

Windows 2000, XP Microsoft Office Minitab

QC Calc Weibull ++7 Access

Visio Microsoft Project FMEA Pro

References Available Upon Request

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