MARK A. ROBBINS

609-***-****

ac9ygt@r.postjobfree.com

*** ******* *****/***. ***, Fayetteville, NC 28314

PROFILE

Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized for ability to develop strong and productive partnerships with customers. Developed, implemented, and successfully achieved ISO-9001-2015, ISO-13485, and ISO-9001-2015/AS9100and TS-16494 certification from BSI and InterTek Systems. Certified RAB IS Consultant and Lead Auditor, Six Sigma certified.

Selected Achievements:

Implemented and maintained quality system strategies, procedures, and activities including defining quality objectives and performance metrics, training, auditing, and corrective actions to ensure conformity to standards while delivering to the business bottom line.

Led and achieved ISO certifications ISO 9001-2008 and 13485based assessments for Medical Device Directive Compliance by European Notified Bodies often changing scope of registration to accommodate business needs.

TECHNICAL SKILLS

Six Sigma Green Belt, Lean Manufacturing, ASQ, SAP, IPC-610 & 7711, KANBAN, Microsoft Office, Form Tool, SPC Minitab.

Global Food Safety Initiative (GFSI) standards (i.e. AIB, BRC, SQF, HACCP).

CNC, CMM, TQM, ASME, FMEA, FTA, OSHA, HACCP, FDA, FAA, GD&T, GMP, PPAP, (21 CFR§ 110, 210, 211, 820, 29 CFR § 1910).

Quality Systems, Project Planning, Gap Analysis, Root Cause Analysis, CAPA, Measures of Performance and Effectiveness, Objectives Matrix Improvement Techniques, Review Test Method Validation, Protocols, Process Method Validations, Batch Record Reviews, Injection Molding Set-Up, and Inspection for Engineering Design Approvals.

Gov’t. Mil-Spec. Requirements, Calibration Systems, (AS9100,ISO/TS 16949:2009, MIL-I-45208, MIL-STD-105D, ISO-9001-2015& ISO-13485/8, EN46001), experience with ASME Section VIII, 10- CFR Appendix B, and NQA-1 quality programs encompassing Sheet Metal Manufacturing, Punch Press and Punch Brake Equipment, Welding Certifications and Processes. NATO Requirements, AQAP’s Allied Quality Assurance Publications, MoD, Ministry of Defense British Standards, Def-Std’s, and Defcon’s.

PROFESSIONAL EXPERIENCE

Coregistics – Cranbury, NJ 2012 – Present

Mfg./ Assembly and Packaging of Pharmaceutical, Medical Device, Cosmetics, Automotive, and Food Products.

Quality Assurance Manager

Responsible for quality assurance function across all shifts in support of production operations.

In partnership with operation management, lead process for continuous improvement of customer satisfaction and compliance. Initiate, review or approve documentation including MPI, SOP, Work Instructions, Quarantines, Investigations, Deviations, Protocols, Complaints, CAPA, Change Controls, and Training records.

Maintain ISO-9001, AS9100, SQF, AIB, and HACCP compliance.

Participate in regulatory agency and customer audits. Maintain required regulatory documentation.

Lead internal / external audits and perform supplier audits. Develop and maintain internal audit program.

Lead development of project specific quality procedures and documents in coordination with customers and internal personnel.

Developed and drove improvements in quality and business systems and processes. Reduced company processes by 37% resulting in first year cost savings of $187K and second year cost savings of $82K due to continuous process improvements.

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ZODIAC AEROSPACE – Logan Township, NJ 2010 – 2012

Aerospace Manufacturing / Aircraft Safety Systems: AS9100, ISO / TS16949:2009

Quality Assurance Manager

Responsible for managing two Quality Engineers and four Quality Inspectors with technical oversight and evaluation of products, parts, PPAP, operational and quality processes.

Analysis and disposition of non-conforming materials including determination of root cause and generation of corrective action plans utilizing statistical process evaluation techniques.

Collected, compiled, and reported data on Cost of Quality and appropriate Key Business Metrics.

Proactively acted on results and provided solutions for corrective action or continual improvement of Quality Management System throughout operations.

Internal Corrective Actions, CAPA, MRB, Supplier Corrective Actions and Customer Quality Issues (QDRs) utilizing skills around Six Sigma analytical principles.

Supported in-house vendor source approval, certification, and completion of efficient program for vendor Quality Assurance through vendor contacts and audits.

Quality improvement through design and drawing review, improvement of inspection and quality control procedures, and evaluation and measurement of operations processes to reduce Non-Quality Costs.

Advised Director of Quality Assurance on planning, staffing, strategies and budgets.

Provided guidance on quality and Lean culture and expectations to Quality Assurance Technicians, Inspectors, and operations.

ST JUDE MEDICAL – Berlin, NJ 2006 –2010

Medical Device Manufacturer

Sr. Quality Assurance Engineer/Supervisor

Managed four Quality Engineers and six Quality Inspectors on two shifts.

Built and updated QSR and MDD- compliant system for R&D and operations.

Site liaison for domestic and international compliance activities including internal and supplier auditing, corrective/preventative actions, and complaints.

Participated in NPD teams, providing input and guidance on areas of quality and design control, corrective/preventative actions, CAPA.

Performed statistical analysis, wrote technical reports and provided support in resolution of product complaints, product problems or safety issues.

Led site certification to Medical Device Directive (MDD) Annex II, ISO 9001, EN46001, and ISO 13485 through BSI. Attained level of credibility with BSI resulting in audit time reduction of 50%.

PURICORE TECHNOLOGIES – Malvern, PA 2004 – 2006

Medical Device Manufacturer

Sr. Quality Assurance Engineer

Developed and implemented processes to produce product that met appropriate regulatory standards, e.g.21 CFR 820 and ISO 13485-2003.Conducted product review and failure investigations with contractors.

Developed and validated methods and instructions for supplier in-process and final product testing.

Maintained metric to monitor quality data for manufacturing yields, failure trending, and quality cost.

CONTRACT ASSIGNMENTS 2000 – 2004

Sr. Quality Assurance Engineer – Johnson & Johnson – Skillman, NJ (2003 – 2004)

Sr. Quality Assurance Engineer / Supervisor – Bristol-Myers Squibb – Skillman, NJ (2002 – 2003)

Sr. Quality Assurance Engineer – CSC Computer Science Corp. – Moorestown, NJ (2000 – 2002)

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EDUCATION / CERTIFICATIONS

RUTGERS UNIVERSITY

BS – Business Management

DELAWARE TECHNICAL & COMMUNITY COLLEGE

A.A.T Analytical Business Techniques

Delaware Technical & Community College /Night School Courses Analytical Business Techniques

Quality Control for Managers, and Quality Systems Applications, Seminar / Technical Seminars

Implementation of ISO-9001/2008, Seminar / BSI / CEEM Reston, VA

Implementation of CMDR & ISO-13485/8, Academia Qualitas/BMS

Aerospace Quality Management System Standard AS9100/AS9200

FDA Certification CFR 110, 820, 210, 211 Seminars/BSI/ CEEM Reston, VA

RAB Certified Auditor - Quality Quest Ltd UK

Six Sigma/Green Belt – Quality Quest Ltd UK

OSHSAS 18001 Standard

Affiliation:

American Society for Quality (ASQ), Medical Device and Quality Management Division.

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