Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

Quality Assurance ~ Quality Systems Management (QSM) ~ Program Development

Supplier Quality Management ~ Regulatory Compliance ~ Process Improvements

         Offer over 20 years experience in regulated industries and extensive talents in directing large-scale initiatives and leading cohesive teams in achieving quality goals in alignment with demanding budgetary, timeline, and quality criteria.

         Advanced expertise in domestic cGMP (Current Good Manufacturing Practices) and international QMS implementations and enhancements.

         Seasoned experience with US and European regulatory agencies, directing risk management efforts, and facilitating FDA-mandated and other third-party audits.

         Possess dynamic communication, negotiation, and interpersonal skills which are instrumental to productively interfacing with all business and project stakeholders.

         Significant expertise in trend analysis, CAPA (corrective and preventative action), training, performance management, and driving measurable process improvements.

Stryker Corporation 2002 to 2017

Senior Manager, Supply Chain Compliance; Global Quality and Operations 2015-2017

         Spearheaded global corporate policy development and implementation including program leadership spanning 800+ suppliers, risk mitigation & management, conflict materials (Dodd Frank Act), and annual SEC / CMR reporting.

         Established, formalized, and implemented supplier code of conduct based on industry best practices.

         Evaluated emerging quality-based regulatory standards, steered risk management, regularly reviewed pertinent legislation, and provided strategic recommendations.

         Drove collaboration across all business divisions and multiple Notified Bodies to harmonize UAV requirements globally.

         Governed policy development to aggressively combat slavery and human trafficking including enforcing compliance with UK Modern Slavery Act.

Senior Manager, Supplier Controls-Orthopaedics & Neurovascular; Global Quality & Operations 2012-2015

         Recruited, developed, mentored, and directed team of 10 across 20 locations worldwide.

         Methodically created and streamlined corporate supplier quality procedures, criteria, and practices.

         Captured more than $5M in annual savings by devising international shared supplier audit scheduling model.

         Centralized quality processes, boosted efficiency, and lowered risks by introducing internal supplier audit scheduling module in TrackWise.

         Played a lead role in defining global harmonized supplier risk management and supplier performance optimization processes.

         Persuasively negotiated and approved corporate & strategic supplier quality agreements, led corporate CAPA resolution, performed supplier metrics reporting, and simplified supplier record retention.

Senior Manager, Supplier Controls-Orthopaedics and Supplier Quality - North America 2012

         Managed, coached, and directed 15 employees during corporate transition, and administered supplier quality audits, supplier quality agreements, supplier nonconformance/CAPA, supplier validation, and supplier quality design transfers activities.

Continued ►

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Senior Manager, Field and Supplier Quality 2008-2012

         Oversaw recruitment, staff leadership, cost control, purchasing, and regulatory compliance among team charged with supplier quality and reporting for Orthopaedics division in US and Europe.

         Championed considerable improvement in post-FDA warning letter remediation.

         Functioned as site leader for third-party audits involving FDA, Notified Bodies, ANVISA, and SFDA.

         Formulated and rolled-out corporate divisional supplier management program, trained key suppliers in purchasing controls, and seamlessly coordinated medical device licensing regulatory activities.

         Directed audits for more than 500 suppliers in 2008, and 275 suppliers each consecutive year to ensure adherence to rigorous quality standards; successfully generated $500K in savings by leveraging third-party resources.

         Pioneered divisional Global Approved Supply List and annual supply base risk assessment.

         Revamped supplier audit team to reduce redundancy and improve efficiency without adding headcount.

         Resourcefully enhanced information organization and access by introducing divisional electronic supplier information filing system.

Manager, Regulatory Compliance & Regulatory Reporting (MDR/MDV & Recalls) 2002-2008

         Recruited, developed, aligned, and mobilized high-performing team of 10 in multi-site regulatory compliance and reporting activities in US and Europe.

         Overhauled and fortified QMS architecture post-merger and synchronized QMS throughout three locations to achieve conformance to cGMPs (QSR), ISO 13485 and CMDCAS.

         Headed MDR and MDV reporting and product recall processes according to 21 CFR 806.

         Conferred with district and center FDA recall personnel to facilitate timely corrections and removals.

         Reinforced hazard analysis tool to determine patient risk and authorize regulatory action (correction/removal) under 21 CFR 806 where required.

         Masterminded field quality management system for Orthopaedics US field branch locations.

         Researched, selected, and implemented division-side LMS to bolster divisional staff knowledge base.

Merrimac Industries, West Caldwell, NJ 1999 to 2002

Vice President, Quality and Supply Chain

         Promoted twice to oversee team of 18 in design, development, implementation, and administration of electronic QMS registered to ISO 9001 for manufacturing operations in NJ, Canada, and Latin America.

         Controlled geographically-dispersed QA engineering, calibration, technical services, purchasing, receiving, inspection, and QC functional areas.

Phillips Consumer Electronics, N.A., Briarcliff Manor, NY 1998 to 1999

Group Manager, Quality and Efficiency-Digital Competency

         Effectively orchestrated QA planning and management including associated software solutions, mechanical testing, QMS, and FCC/UL/CE compliance.

General Bearing Corporation, West Nyack, NY 1997 to 1998

Manager, Corporate Quality Assurance

         Shepherded QMS (design, development, implementation, maintenance), calibration, QA/failure analysis engineering, and multi-site quality control operations.

Prior Roles:

Director, Quality Assurance / ISO Coordinator, Mikron Instrument Company, Oakland, NJ

Director, Total Quality Management, Arlington Press, Brooklyn, NY

MBA, Quality Management Systems, Fordham University Graduate School of Business, New York, NY

Bachelor of Arts, Brandeis University, Waltham, MA

Certification in Managing End-to-End Supply Chain, Rutgers Business School / Center for Supply Chain Mgmt.

QMS Lead Assessor Certificate #6301951, Perry Johnson Registrars

ASQ CQA Certificate #12333

Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

INSERT DATE

[HIRING MANAGER S NAME]

[COMPANY]

[ADDRESS]

[CITY, STATE, ZIP CODE]

Dear Hiring Manager:

Please accept this letter and accompanying resume in application for the (INSERT POSITION) opportunity that is currently available with (INSERT COMPANY NAME). In advance, thank you for your time and consideration.

As indicated in the accompanying resume, I bring to you an outstanding background in full-scope supplier quality management, significant experience in QSM implementation, and considerable expertise in continuous improvement, risk management, and global regulatory compliance. My extensive experience in overseeing all aspects of quality operations for highly regulated industries will undoubtedly prove to be an immediate asset to your company. I possess exceptional academic and professional credentials, and have successfully recouped millions of dollars in savings through expertise in the complete spectrum of QA operations. To complement these qualifications, I offer an excellent blend of skills in government relations, documentation, and program administration which are vital as a (INSERT TARGET POSITION).

As an influential addition to your senior leadership team, you will find that I am remarkably positioned to guide (INSERT NAME OF COMPANY) in not only attaining, but exceeding its quality assurance goals. I am eager to discuss how my qualifications uniquely match your current and future needs, and look forward to interviewing with you in the near future.

Sincerely,

Yyyyyy x. yyyyyy

Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

(INSERT DATE)

(INTERVIEWER S NAME)

(TITLE)

(COMPANY NAME)

(ADDRESS)

(CITY/STATE/ZIP CODE)

Dear _______________________:

I would like to thank you for providing me the opportunity to interview with you and discuss the (INSERT TARGET POSITION) position currently available with (INSERT COMPANY NAME). Having gained a deeper insight into the job requirements and your objectives, I am confident you will find me to be an integral participant in achieving your goals.

As discussed, I am a highly experienced executive leader eager to launch a successful career as a dedicated member of your senior management team. I believe you will find my dynamic (LIST A FEW SKILLS OR QUALIFICATIONS RELEVANT TO THE POSITION) skills vital to your operations and look forward to contributing to your success.

Should you have any additional questions, or to discuss future employment opportunities, please feel free to contact me at your earliest convenience. Again, thank you for the enlightening interview. I look forward to your response.

Sincerely,

Yyyyyy x. yyyyyy