Sharon Costa

*** ******** ***** ****, ***** Dartmouth, MA * ac7hpn@r.postjobfree.com * 508-***-**** (mobile)

Professional Summary

Quality Assurance leader with a proven track record of strategic QA vision, skilled at resolving long-standing problems and creating solutions that improve operational efficiency and quality. Skilled at business process improvements, using Lean methodologies. Balances customer and business needs to drive strategic and tactical decisions. Expertise includes:

Project Management

Experienced ISO 9001 Auditor

Cross Functional Organization

Root Cause & Corrective Action

Customer Relationships

Quality System Design & Implementation

Industry Experience

Accudynamics, Lakeville, MA

Accudynamics attributes: Reliable precision manufacturer, optimizing design for manufacturing (DFM) from concept through prototype to production. Precision manufacturing services are used by medical, scientific, and industrial OEMs in MA and around the world, ISO9001, non-union.

Quality Control Manager (March, 2017 – Present)

Manages seven direct reports: Quality Control Inspectors (3), Quality Control Programmers (2) Document Control Specialist (1), and Quality Control Specialist (1).

Manages day to day activities in quality lab to ensure pre-plate, post-plate and incoming inspection is done timely in order to satisfy OTD of customer orders.

Managed quality assurance standard procedures to successfully pass ISO registrar audit for ISO 9001:2015. Also trained employees to become internal auditors.

Manages calibration system, including scheduling calibration of all shop tools, CMM’s, surfaces plates and more. Request quotes for calibration and repairs, PO’s and track paperwork to invoice payment.

Manages employee training, including database maintenance, tracking and communicating training requirements.

Manages CPA, RMA, MRB and customer complaints including database maintenance from entry to closure. Developed metrics, monitored and implemented changes to improve metrics and become more efficient.

Implemented OPL (One Point Lessons) to raise awareness and train employees on customer complaints and issues.

Implemented DCR (Document Change Requests) process in order to streamline process to change documentation.

Tecomet, formerly Symmetry Medical OEM Solutions, New Bedford, MA

Tecomet attributes: Leader in net shape forging, photochemical etching, precision machining, and metal joining of critical components and complex assemblies for the medical implant, aerospace/defense and specialty commercial/industrial markets, ISO9001 ISO13485 AS9100, non-union.

Document Control Supervisor (March, 2015 – March, 2017)

Managed three direct reports: Senior Quality System Specialist (2) and Document Control (1).

Managed employee training, including database maintenance, tracking and communicating training requirements.

Responsible for maintaining label software, hardware and label database.

Site Champion for data management software and maintains electronic logs and metrics for tracking Document Control and DAT Center performance.

Managed all levels of Document Control system (EtQ), customer requirements and coordinates with other sister sites with regards to shared customer documentation.

Assisted with the preparation of ISO Quality internal audits and final quality audits including label and IFU reconciliation.

IDEX Health & Science, Middleboro, MA

IDEX H&S attributes: High mix/low volume and low mix/high volume manufacturing of fluidic devices and components - primarily servicing the IVD, Analytical Instruments and Biomedical markets, ISO9001, non-union

Quality Assurance Manager (December, 2013 – March, 2015)

Managed four direct reports: Quality Control Inspectors (3) and Document Control (1).

Managed CAPAs, RMAs, Process Deviations and Product Data Management. Led RIE (Rapid Improvement Event) for PDM (new part setup in MRP system) reducing lead time from 19 days to 5 days.

Responsible for measuring effectiveness & reporting of quality systems to executive team.

Served as key administrator for quality software program. Key technical resource for other business units.

Developed and maintains quality on-boarding training for key processes, such as Quality Management System including SOPs and work instructions. Trained employees on regulatory requirements, software applications and general quality processes.

Responded to customer requests for surveys, Certificate of Compliance/Conformance and general information.

Responsible for certification of RoHS and REACH to customers.

Reduced incoming inspection from 23 days to 7 days in 3 months on various products by analyzing incoming data and non-conformances to move qualified items to DTS (Dock-to-Stock).

Internal Auditor for ISO 9001

Quality Coordinator (December, 2011 – December, 2013)

Coordinated Product Development Process, specifically focusing on integrity of documentation throughout the process, as well as ensuring adherence to the PDP process throughout the phases/gates.

Key team member in the development of the quality roadmap to transform facility to a competitive quality level.

Preserved and sustained Quality Management System including training personnel on procedures.

Wrote and revised procedures to support QMS. Execution of own internal audits, assisted and final review of team members’ internal audits. Instrumental in the achievement of ISO 9001 certification.

Responsible for certification of RoHS and REACH to customers.

Through effective root cause methodologies & corrective/preventative actions, reduced PPM from 7000 to 2400 (some months <500 PPM).

Managed three interns in projects which resulted in quicker response time to customers for RoHS certs, organization of prints and documents to allow for easier retrieval, and cleanup of data for easier transfer for MRP implementation.

Project Manager for preparation stages of MRP Implementation. Led local business unit in developing the project plan and coordinating the various activities across customer service, product management, purchasing, manufacturing, and finance for a successful implementation.

Engineering Project Specialist (July, 2007 – December, 2011)

Responsible for organizing and leading projects to completion. Successfully implemented a file management system from one directory to another which aided in improved time management, and ease of file accessibility.

Successfully implemented a customer complaint process/form through Microsoft Outlook, allowing customer service and sales representatives to enter customer complaints for easy transfer to the Quality Management System where the complaint could be tracked.

Led Engineering Change Order (ECO) process. Reduced lead time from 23 days to 10 days (56% reduction) using Lean and Value Stream concepts.

Designed Access databases for processes which included RMA, NCMR, CAR, and Process Change Control. Responsible for training and managing these processes.

Performed machine qualifications using Minitab (Histograms, Two-Sample T- Tests) for facility relocation. Qualified over 60 machines which enabled a successful facility transition and minimal lead time impact to customers.

Detail Drafter (January, 2004 – July, 2007)

Converted AutoCAD drawings to Solid Works models and prints.

Developed designs and proofs of concept of components and assemblies for manufacturability and assembly.

Education

Wentworth Institute of Technology – Boston, MA

Project Management, Bachelor of Science, August 2013

Dean’s List, Spring and Summer 2012, Spring 2013

Magna Cum Laude

Bristol Community College – Fall River, MA

Mechanical Engineering Technology, Associates of Science, December 2005

Honors

Languages: English (native), Portuguese (fluent)

Computer Skills: AutoCAD, Solid Works, Minitab, Project software (Microsoft Project, Visio, Power Point), Microsoft Office, Windows, MRP systems (JDE, Visual, Epicor 9, JobBoss), EtQ Reliance, UniPoint and QCBD expert (quality software systems).

Formal Skills Training

ISO 9001:2015 Internal Auditor Training, December 2017

ASQ Certified Quality Auditor, Cert. No. 65705, June 2016

ISO 9001:2008 Internal Auditor Training, February 2011

Access 2007 Advanced Training Certificate, June 2010

Access 2007 Basic Training Certificate, March 2010

ISO 9001:2000 Internal Auditor Training, August 2007

Computer Aided Design and Drafting Certificate, 2005

Contact this candidate