Quality Assurance System
Resume:
JOHN P. DETRES
Spring Hill, FL 34604
Mobile 352-***-****
************@*****.***
Professional Summary
A strong track record of accomplishments in all aspects of product quality, quality system management and regulatory compliance. A dedicated team-oriented individual fluent in both Spanish and English. Areas of significant experience include:
Product Quality
Statistical Process Control
Supplier Quality Engineering
Reliability Monitoring
Quality System Compliance
Certified Six Sigma Green Belt
New Product Qualification
ISO 13485/ISO 9001/AS9000 and FDA (21 CFR)/International Documentation
Standards.
Failure Analysis and Reporting
FDA/cGMP/GDP Compliance
Regulatory Compliance
CAPA Process including Root Cause Analysis
Customer Complaint Handling
Professional Experience
Brasseler USA 2019 to 2025
Savannah, Georgia
A medical manufacturer of high-quality instruments for healthcare professionals specializing in Restorative Dentistry, Endodontics, Prosthodontics, Periodontics, Orthodontics, Pedodontics, Oral-Maxillofacial Surgery, Dental Hygiene, and Dental Laboratories.
Senior Manager Quality Systems
Provide daily leadership and management for the Quality System (QS) team.
Establish, maintain, and develop continuous improvement of the Quality System procedures and processes.
Act as the QS subject matter expert and resource leader for Quality Assurance and Regulatory Compliance to deliver effective results.
Work in a cross-functional environment to identify process and system improvements to enhance efficiency and improve process performance while maintaining compliance.
Lead, influence, and negotiate to achieve business strategies and deliver results on time.
Develop and implement measures and metrics to monitor QS and present to executive management.
Lead the Quality System Management Reviews to ensure QS is suitable, adequate, and effective.
Provide leadership and oversight of the CAPA system and sub-processes.
Establish, maintain and implement Quality System training to the entire organization including a system to maintain training records.
Develop annual quality plans and objectives and ensure commitments are met and effective.
Serv as the technical expert of QS, Management Controls for the organization.
Represent QS Management Controls during regulatory inspections and notified body audits.
Provide inspection support, inspection readiness, execution (front room and back room) and post inspection activities.
Orthomerica Products Inc. 2007 to 2019
Orlando, Florida
A manufacturer of Classes I and II Orthopedic products serving the medical industry,
Quality Assurance Manager
Quality Assurance Manager directing the day-to-day activities of the Quality Assurance Department, managing its activities within allocated budget resources and directly supervising the personnel within the department.
Corporate Management Representative for the Product Assurance/Quality Control discipline and Certification Activities.
Quality Assurance, Quality Inspection, Quality Auditing, Regulatory Compliance, Documentation Control and Documentation Library System.
Generally responsible for all quality-related activities including the management of the process quality inspection team.
Design Control process activities including (Design Reviews, Inputs, Outputs, Verification, Validation and Design Transfer)
ISO 13485 Registered Quality System Management Representative with responsibility for maintenance and improvement of this system.
Responsible for Food and Drug Act (FDA) compliance for the manufacture of all Class II Medical Products.
Continuously work directly with customers and employees to identify and evaluate problems make recommendations, and initiate effective solutions.
Determine departmental priorities and projects while promoting continuous Quality improvements.
Manage and supervise Quality System activities and quality organizational personnel.
Review research, testing quality control and other operational reports to ensure that quality standards are met.
Responsible for Supplier Quality Management activities including incoming and outgoing inspection as well as corrective actions and audits.
Maintain standardized Quality Assurance policies and procedures.
Six Sigma green belt participating in company’s continual improvement programs with use of statistical techniques such as (SPC).
Root cause analysis with use of analysis tools such as (5Why’s and Fishbone Diagrams).
Monitor quality assurance/control criteria for finished products.
Regulatory Compliance Officer maintaining compliance with all regulatory requirements including (FDA/cGMP, QSR, MDD, EU and CMDCAS Canadian Medical Device Regulation)
Prepare Technical Files (CE Mark) to support the multiple product lines.
Maintained up to date knowledge of applicable federal and local cGMP regulations and guidelines.
Leadership for the strategic development of regulatory submissions related to new medical devices development.
Review changes in regulatory landscape and reporting for management review.
oEvaluate regulatory changes and identified action plans to assure company compliance to changing regulatory requirements.
Responsible for the communication of regulatory requirements to other departments and employees.
MtronPTI 2005 to 2007
Orlando, Florida
A manufacturer of frequency control products serving the telecommunications, industrial, military, and space product markets generating revenues in excess of $40 million.
Quality Manager
Joined PTI during the merger of the company’s operation with Mtron Industries which then became MtronPTI. The operation grew from an initial output of approximately $20M per year to in excess of $40M per year. Generally responsible for all location quality related activities including the management of the process quality inspection team.
ISO 9001:2000 Registered Quality System Management Representative with responsibility for maintenance and improvement of the Quality System (QS).
Continuously work directly with customers and employees on the shop floor to identify and evaluate problems and to recommend and initiate effective solutions.
Determine departmental priorities and projects while promoting continuous Quality improvements.
Manage and supervise Quality system activities and quality organizational personnel.
Review research, testing quality control, and other operational reports to ensure that quality standards are met.
Manage supplier quality activities including incoming and outgoing inspection as well as supplier corrective actions and audits.
Maintain standardized Quality Assurance policies and procedures.
Trained as Six Sigma green belt participating in company’s continual improvement program.
Monitor quality criteria for finished products.
Vectron International 1996 - 2005
Hudson, New Hampshire
A manufacturer of frequency control products serving the telecommunications, industrial, military and space product markets generating revenues in excess of $150 million.
Senior Quality Engineer
Joined Vectron during the initial start up of the company’s operation as it transferred production from AT&T following the acquisition of the frequency control product group by Vectron. The operation grew from an initial output of approximately $30M per year to in excess of $150M per year. Generally responsible for all location quality related activities including the management of the process quality inspection team.
Established and maintained calibration function for all development and production related equipment.
Led product qualification efforts for the entire range of oscillator, SAW, and optical products to industry standards such as Bellcore, Mil Std, and IEC.
Responsible for reliability monitoring program including environmental stress testing, electrical testing and mechanical testing, implemented, managed and involved in the scripting and writing of various test programs with the use of Visual Basic and advanced Basic programming.
Conducted analysis on all product failures returned and prepared initial feedback reports.
Participated in the implementation of ISO-related procedures and processes enabling company to achieve ISO 9000-1994 std as well as migration to ISO 9000-2000 std.
Certified as internal auditor for compliance to ISO standards.
Responsible for supplier quality management activities including incoming and outgoing inspection as well as supplier corrective actions and audits.
Documentation control coordinator.
oImplemented and managed various access databases for document control function.
Trained as Six Sigma green belt participating in company’s continual improvement program.
Oasis Imaging Products 1995-1996
Hudson, New Hampshire
A manufacturer of laser printer equipment for personal and industrial use including printers, cartridges and toner.
Production Supervisor
Supervised production and technical support personnel for the 1st and 2nd shift operations.
Recruited and trained direct labor personnel to support production requirements.
Supported new product evaluation and introduction.
Provided technical engineering support for development of manufacturing processes and facilities.
Various - Part time employment during school 1992 to 1995
Education
Interamerican University – San German, Puerto Rico Graduated 1994
BS in Electronics Engineering
Additional Training
Electronics Technology
Professional Memberships/Technical Presentations and Certifications
Member of ESD/EOS Association, ASM International Society, American Society for Quality
Attended the 1999 ESD Symposium – presented paper on ESD control and management in oscillator manufacturing.
Attended and participated a Root Cause Analysis Course
ISO 9000 Internal Auditor Certification
ISO 13485:2016 Internal Auditor Certification
FDA Quality System Requirements ; 21 CFR, Part 820 Internal Auditor Certification
MDSAP Internal Auditor Certification
Sis Sigma Green Belt Certification
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