Patricia Moscatelli

** ****** ******

Northbridge, MA 01534

720-***-****

PROFESSIONAL EXPERIENCE:

*/**-******* *** ***********, Lafayette, CO – ISO Quality Systems Consultant (P/T)

*/**-***sent High Purity New England, Smithfield, RI – Documentation Control Specialist

IS0 9001:2015 and ISO 13485:2016, Responsible for facilitating and maintaining the Change Control, Document Control and Deviation Process within HPNE. Monitor and maintain the scanning, saving, and filing of all Batch Records upon product release. Ensure compliance to GMP, Quality System and Procedures.

10/17-7/19 RMI Laser, Lafayette, CO – QA/ISO Manager/Custom Project Manager

Manage and support PDT lab, testing of all pre-departure lasers. ISO 9001:2015 full responsibility to standard throughout organization. Plan, coordinate, and direct quality program designed to ensure quality control and quality assurance of the production of products consistent with established standards. Work closely with ME/EE/SW developments to adhere to schedules and customer specifications on custom design lasers and cabinets.

5/12-10/17 CCX Corporation, Lafayette, CO – ISO Quality Systems Manager Worldwide

Manage the QMS database in compliance with ISO 9001:2015 standard within a manufacturing environment, internal/external audits, corrective and preventive actions. Responsible for creation, implementation of process, procedures, disposition and control of RMAs, NCRs, CAPA and vendor assessments. Monthly metrics of OTD, efficiencies, lot acceptance, and rework stats. Conduct MRB meetings, Production Review and Management Review meetings. Creation of ROHS and REACH certificates for customers.

10/10-4/12 REO, Boulder, CO – Planning Admin/Scheduler (Contract)

ECO business review and signoff, RMA reports and disposition, report of all Planner stats daily and late or on-time status to customers. Coordinate job orders to MFG floor. Create EXCEL reports to upper management of all OTD and SFM stats. Maintain company compliance to the Quality Management System (QMS) per ISO and FDA requirements. Implementation of policies/documentation in accordance with the QMS. Corrective/Preventive Action, Quality System Non-conformance, and RMAs. Assist in conduction and reporting of Quality Audits.

2009-2010 Intrex Aerospace, Louisville, CO - Quality Control (Contract)

Maintain company compliance to the Quality Management System (QMS).

Collects information/data on nonconformities on incoming material, work in process, finished parts, and communicates them to the organization verbally and through the nonconforming parts procedures. Develops quality system procedures and processes and provide training. Conduct floor audits and create corrective action if needed. Maintain Approved Supplier List and communications with suppliers.

2006-2007 Mountainside Medical, Boulder, CO - Quality Control/Doc Control (Contract)

Maintain company compliance to the Quality Management System (QMS) per ISO and FDA requirements. Implementation of policies/documentation in accordance with the QMS. Completion of any Corrective Actions or customer complaint closures, Corrective/Preventive Action, Supplier Corrective Action, Quality System Non-conformance, and Nonconforming Material. Assist in conduction and reporting of Quality Audits, (Internal and External). Maintain Approved Supplier List and communications with suppliers. Creation and Implementation of: Work Instructions, Receiving Inspection Reports, Quality Control Plans and Manufacturing Inspection Reports Complete product certifications. Verify final inspection closure reports.

1998–2006 ERICSSON WIRELESS COMMUNICATION, Boulder CO - Hardware Engineer

Design and document a variety of CDMA telecommunication machines. Design complex high volume systems from concept to production. Maintain designs, revision control and contribute to the evolution of products. Awareness of power and mechanical systems and exposure to manufacturing processes. Design/maintain high tech telecommunication equipment. Qualcomm sold to Ericsson in May 1999.

1992-1998 QUANTUM CORPORATION, Shrewsbury, Ma. – SR. Mechanical Designer

Design and document a wide variety of tape, disk and head products. Create/file and structure all levels of documentation from concept to completion. Work with designer of each team to ensure product time schedules. Quality Systems Improvement Team Site Representative, responsible for ISO compliance from a design engineering perspective.

1980-1992 DIGITAL EQUIPMENT CORPORATION, Maynard, Ma. - Mechanical Designer

Design layouts of plastic, sheet metal, and harnesses, of small and large system computers. Create detailed documentation packages and create multilevel of assembly structures. And product development, Disk Drive division sold to Quantum.

EDUCATION:

Blackstone Valley Reg. Voc. Tech. High School 1980 graduated with honors in mechanical design.

Northeastern University – Various Engineering courses

Ongoing professional education from employers

SUMMARY OF QUALIFICATIONS:

- Highly motivated, detail oriented, drives products from conception into production.

- Strong in leadership/communication skills meets or exceeds deadlines.

- AS9100C quality auditor and certified operator. ITAR trained

- ISO 9001:2015 Process Based Internal Auditing trained

- Computer skills: PROE, MICROSCOFT, M2M, VANTAGE, OMNIFY, MACOLA, ACCESS, GAGEtrak