Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

Joseph Satek

Winter Garden,FL

Summary

Dynamic Quality Manager with over 15 years of experience in the manufacturing industry, specializing in medical devices. Proven track record in leading cross-functional teams to drive quality improvement initiatives, enhancing product reliability, and ensuring compliance with ISO standards. Adept at developing and implementing robust quality management systems that optimize operational efficiency and elevate customer satisfaction.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Quality Manager

Oceaneering International
07.2020 - Current
  • Led a remote quality team of 6, consistently holding each member accountable to meet critical internal and external deadlines, regardless of challenges.
  • Achieved $4.5M COPQ reduction by performing root cause analyses and driving effective, long-term corrective actions across departments.
  • Decreased non-conformances and CAPAs by 25% through proactive training and robust auditing practices.
  • Successfully implemented Quality Management Systems (QMS) in alignment with ISO standards, embedding a culture of operational excellence.
  • Acted as global expert in Root Cause Analysis and PFMEA, training teams worldwide on resolving complex quality issues effectively.
  • Conducted regular internal audits, standardized quality procedures, and proactively managed risks to ensure consistent product reliability.
  • Mentored and empowered team members, promoting accountability, skill development, and sustained high performance.

Senior Quality Engineer

Oceaneering International
09.2019 - 07.2020
  • Led quality planning and validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring consistent compliance and high-quality standards.
  • Performed in-depth supplier audits, source inspections, and evaluations, proactively identifying risks and driving improvements in supplier performance.
  • Managed supplier defect reduction initiatives, achieving a 20% decrease in defects through comprehensive audits, effective corrective actions, and statistical analysis (Minitab).
  • Tracked and reported Key Performance Indicators (KPIs) to monitor process effectiveness, proactively preventing product, process, and system nonconformities.
  • Collaborated with cross-functional teams to implement process enhancements, swiftly resolving complex quality issues.
  • Oversaw supplier change notification processes, ensuring timely, effective communication and execution of improvements across supply chains.
  • Designed inspection protocols and training materials for remote teams, verifying accurate implementation and data collection.
  • Facilitated supplier onboarding and qualification, ensuring rapid alignment with company standards, compliance expectations, and quality requirements.
  • Provided mentorship and technical guidance to junior engineers, fostering skill growth, accountability, and adherence to quality practices.
  • Acted as a quality expert, supporting internal stakeholders in interpreting standards, developing corrective actions, and implementing industry best practices
  • Led Quality Management Reviews for Africa and Middle East regions.

Senior Quality Assurance Engineer

Oceaneering International
09.2017 - 09.2019
  • Created supplier scoring system, enabling data-driven decisions by management.
  • Tracked and improved KPIs, enhancing logistics and supplier performance.
  • Reviewed QA investigation reports, ensuring procedures were followed and issues resolved.
  • Analyzed and presented statistical quality data clearly to management.
  • Led CAPAs, removing roadblocks to ensure timely project completion and recurrence prevention.
  • Conducted inspections and audits at key suppliers, reducing risks and improving reliability.
  • Performed root cause analysis, using fishbone and interrelationship methods for effective solutions.
  • Implemented process improvements to reduce errors, costs, and enhance productivity.
  • Reviewed engineering drawings and change requests, ensuring quality requirements were met.
  • Collaborated with finance team as Green Belt, supporting quality-driven cost-saving initiatives.
  • Worked with Material Review Board, providing technical justification for non-conformances.
  • Trained global teams on quality standards and procedures, boosting compliance.
  • Supported ISO 9001 audits, ensuring compliance and readiness.
  • Developed and enforced Inspection and Testing Plans (ITPs) and Incoming Quality Control procedures.

Senior Quality Engineer

Interplex Sunbelt
03.2014 - 09.2017
  • Collaborated with engineering teams during design reviews to ensure parts could be easily inspected and manufactured.
  • Improved development and testing processes for better product performance and compliance.
  • Led validation of medical components and processes, ensuring alignment with ISO 13485 and 21 CFR 820.
  • Authored and executed protocols, test plans, and reports to support regulatory and quality requirements.
  • Trained teams on validation, testing, and documentation standards.
  • Performed root cause analysis and drove corrective actions.
  • Enhanced inspection processes, documentation, and workflow methods.
  • Mentored junior engineers and provided input on performance evaluations.
  • Partnered with QC teams to complete inspections and reviews.
  • Developed ISO 13485-compliant training protocols for quality procedures.
  • Led product inspections and applied medical device quality standards.
  • Reported quality metrics and statistical trends to leadership.
  • Supported external audits and regulatory inspections, including ISO and FDA.
  • Managed customer complaints and supplier audits, ensuring full compliance.

Quality and Regulatory Affairs Manager

IPI Medical Products
12.2011 - 03.2014
  • Owned all Quality Management Systems to ensure compliance with ISO 9001, ISO 13485, 21 CFR 820, and EU regulatory standards.
  • Built the entire QMS from the ground up, aligning with ISO, FDA, and European requirements.
  • Interfaced with FDA auditors and quality system registrars, ensuring successful inspections and certifications.
  • Managed all customer quality interactions, including complaints, internal audits, and supplier audits.
  • Led corrective and preventive action (CAPA) processes, driving continuous improvement across operations.
  • Performed Statistical Process Control (SPC) to monitor and improve process capability.
  • Oversaw calibration programs for all measuring and test equipment.
  • Developed PFMEAs and control plans, improving process reliability and risk management.
  • Created improved methods for in-process, raw material, and incoming inspections to enhance defect detection.
  • Identified root causes of defects and recommended adjustments that reduced rework and scrap.
  • Cut assembly production time by 50% by developing and implementing lean process improvements.
  • Suggested and implemented quality and cost-saving initiatives, supporting both compliance and operational goals.
  • Managed regulatory filings and correspondence, ensuring timely and accurate submissions.
  • Consulted with regulatory bodies to maintain product compliance across all regions.
  • Led internal audits, customer surveys, and on-site evaluations to maintain QA program effectiveness.
  • Conducted ISO-compliant management reviews, presenting key metrics and improvement plans to leadership..

Quality Manager

Westlake Plastics
09.2007 - 04.2011
  • Led a team of 8 in managing all QA functions across medical, industrial, and aerospace products.
  • Owned and maintained QMS in compliance with ISO 9001, ISO 13485, AS9100, and FDA requirements.
  • Served as Lead Auditor for internal, supplier, customer, and registrar audits.
  • Handled all customer quality interactions, including complaint resolution and corrective actions.
  • Performed SPC, root cause analysis, and implemented process improvements to reduce defects.
  • Oversaw calibration of measuring devices and lab equipment.
  • Directed supplier development and qualification activities.
  • Conducted material testing per ASTM standards and ensured compliance with quality specifications.
  • Developed and maintained dimensional part specifications, control plans, and work instructions.
  • Improved quality processes to enhance efficiency, reduce cost, and ensure compliance.
  • Managed all quality documentation and supported audit readiness.
  • Demonstrated expertise in material defects and provided technical input to cross-functional teams.

Quality Supervisor

Graber-Rogg
07.2005 - 09.2007
  • Operated all molding machine types and performed mold/machine setups to meet production schedules.
  • Conducted preventive maintenance and executed all required product inspections to ensure quality standards.
  • Handled shipping and receiving, and actively supported the MRP system rollout
  • Contributed to product development by creating PFMEAs, Control Plans, and operator-friendly visual work instructions.
  • Rewrote ISO 9001 documentation and served as Lead Auditor, training internal auditors and conducting audits per ISO 9001, QS 9000, and TS 16949.
  • Performed SPC on manufacturing processes and identified trends to reduce variability.
  • Developed a warehouse labeling method to better identify WIP and finished goods.
  • Provided backup IT system support and filled in as Lead Operator when needed.
  • Demonstrated strong understanding of material defects and recommended improvements to reduce quality issues.
  • Suggested and implemented process changes that improved quality, reduced costs, and enhanced the production environment.
  • Supervised a team of 6 inspectors, overseeing daily operations and offering technical guidance.
  • Maintained and coordinated inspection equipment maintenance and service.
  • Created monthly QA reports summarizing inspection data and improvement efforts.
  • Managed QA programs and tracked quality issues across customers, suppliers, and internal operations.
  • Recorded and distributed key statistical information to drive quality decisions.

Quality Assistant

International Systems Solutions
11.1999 - 07.2005
  • Computer graphic arts and power point preparer of training materials and sales promotional presentations charts, graphs and pictorials in support of family owned quality systems consulting business
  • Preparing quality assurance documentation and systems conceptual models for clients seeking ISO 9001 quality system certification
  • Assisting clients in the preparation of their websites

Education

Bachelor of Science - Business, Specializing in Project Management

Devry University
Chicago, IL
2018

High School Diploma -

Hopewell High School
Aliquippa, PA
1998

Skills

  • Proficient in Microsoft Office
  • ISO9001, ISO13485, AS9100, ISO/TS 16949
  • Quality Management Systems
  • Process improvements
  • Statistical Process Control
  • Root Cause Analysis (TapoRoot, Apollo, Ishikawa, etc)
  • Validation expertise (IQ, OQ, PQ)
  • Blueprint interpretation expertise
  • Proficient in Minitab, Power BI, Windchill, SAP, CATSWeb
  • Supplier Onboarding and auditing
  • PPAP, PFMEA, DFMEA, APQP
  • Internal and Supplier Change Management

Accomplishments

Six Sigma Green Belt

Lead Auditor ISO 9001

Certification

  • Advanced Prompt Engineering - Certificate # VX47ZHTTC8BJ


  • Prompt Engineering for ChatGPT - Certificate # 7PZYS1R3KVYF

Timeline

Quality Manager

Oceaneering International
07.2020 - Current

Senior Quality Engineer

Oceaneering International
09.2019 - 07.2020

Senior Quality Assurance Engineer

Oceaneering International
09.2017 - 09.2019

Senior Quality Engineer

Interplex Sunbelt
03.2014 - 09.2017

Quality and Regulatory Affairs Manager

IPI Medical Products
12.2011 - 03.2014

Quality Manager

Westlake Plastics
09.2007 - 04.2011

Quality Supervisor

Graber-Rogg
07.2005 - 09.2007

Quality Assistant

International Systems Solutions
11.1999 - 07.2005

Bachelor of Science - Business, Specializing in Project Management

Devry University

High School Diploma -

Hopewell High School

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