Summary
Overview
Work History
Education
Skills
Certification
Hobbies and Interests
Affiliations
References
Timeline
Generic
Alwyn Jennings

Alwyn Jennings

Cork

Summary

Experienced professional with over 20 years in regulated environments, handling roles of increasing responsibility in multinationals like DePuy, Stryker, and Tecomet. Skilled in project management, senior quality engineering, team leadership, and quality management. Proficient in areas such as medical device manufacturing, clean rooms, supply chain, supplier quality, new product introduction, non-destructive testing, and design. Currently serving as Quality and Regulatory Director for Europe and Asia with primary responsibility for international manufacturing compliance. Additionally, serving as interim General Manager for Cork-based manufacturing facilities since August gaining further insights into financial and production aspects of the business

Overview

22
22
years of professional experience
1
1
Certification

Work History

Quality and Regulatory Director Europe, UK and Asia

Tecomet
01.2024 - Current
  • Company Overview: Tecomet is the world’s largest sub-contractor of Medical devices with 17 sites in the US, Europe, UK and Asia and offers expertise in producing medical devices for top OEM medical device and Aerospace manufacturers,
  • As the Quality and Regulatory Director, I am responsible for ensuring quality assurance and regulatory compliance across Non U.S sites in medical device and aerospace manufacturing
  • My responsibilities include developing and implementing quality management systems to ensure adherence to industry standards and regulations such as ISO 13485, FDA 21CFR part 820, and AS9100
  • I lead a team of quality assurance professionals to conduct audits, inspections, and risk assessments to identify areas for improvement and ensure continuous compliance with regulatory requirements
  • All Quality Managers with Management Representative Responsibilities for these sites report directly to me. then I report directly to the EVP of Quality
  • I collaborate with cross-functional teams to integrate quality and regulatory considerations into product development processes, ensuring that all products meet or exceed customer expectations and regulatory requirements
  • I also serve as the primary liaison with regulatory agencies, providing support during inspections and submissions to facilitate product approvals and maintain regulatory compliance
  • Through strategic planning and proactive risk management, I contribute to the company's success by ensuring the safety, quality, and regulatory compliance of our products in the medical devices and aerospace manufacturing industries
  • I ensure all sites maintain a high level of Audit and Inspection readiness
  • Provide on-site support during FDA and PMDA inspections to ensure compliance
  • Managed budgeting and financial planning for all Quality expenditure in the OUS organization.
  • Identified opportunities for improvement in Site Specific Compliance metrics.
  • Cultivated strong relationships with customers by responding promptly to inquiries or complaints.

Quality and Regulatory Manager & Management Representative

Tecomet
06.2019 - 01.2024
  • Management Representative and Quality manager for the two Tecomet manufacturing facilities in Cork Ireland producing MDR Class III medical devices (Plastics and Metal) reporting directly to the EVP of Quality
  • Developed and implemented quality management systems in compliance with FDA and ISO regulations, elevating the Irish facility to become the top-performing Tecomet site based on Quality KPIs.
  • Managed New Product Introductions for multiple customer launches, ensuring timely approvals and compliance with applicable standards
  • Responsibility for managing Furls and FDA registrations for the site and scheduling for ISO 13485 Certification audits
  • Ensured all elements of the Quality Management System was maintained and compliant with regulatory requirements and quality standards
  • Collaborated with cross-functional teams to resolve quality issues and implement corrective actions
  • Oversaw risk management activities to mitigate potential hazards and ensure product safety
  • Oversaw customer complaints and ensured customer requests were responded to in a timely manner
  • Supported Regulatory body audits and inspections in Cork and at other Tecomet sites
  • Overall responsibility for Training, Doc Control, Quality Engineering, NPI, Calibration, Change Control, Vendor Management, Quality Systems, Inspections, NC/CAPA, customer complaints and Auditing
  • Reviewed proposed changes in regulations, and policies that could impact the organization.
  • Identified areas of non-compliance within the organization and developed corrective action plans.
  • Directed recruitment to ensure headcount was maintained which involved interviewing and coaching newly hired staff.
  • Oversaw and coordinated all onsite Audits conducted by regulatory bodies

Quality Assurance Manager

OrthoXel
07.2018 - 06.2019
  • Company Overview: OrthoXel is an Irish ISO13485 2016 certified and FDA registered Medical Device Company
  • Its primary components are intramedullary nails and the accompanying surgical instrumentation kits
  • Responsible for maintaining supplier controls, conducting supplier audits, and managing supplier non-conformances.
  • I managed the completion of annual supplier performance reviews and was also involved in the sourcing and supplier selection and reviewingthe supplier certification for the services being provided and ensuring quality agreements were in place.
  • Maintained accurate calibration records, ensuring compliance with industry regulations.
  • Oversaw the management of customer complaints and performed Health Hazard Evaluations, coordinating with surgical/medical professionals when required.
  • Enhanced organizational workflows at OrthoXel with the successful implementation of PPAP, a production approval process, and pFMEA.
  • I ensured the appropriate personal were trained to the correct documents and that it was completed in a timely manner
  • Oversaw Management reviews and conducted monthly Quality Meetings
  • Maintained and tracked Quality metrics, Change Control system, and Doc Control.
  • Managed internal non-conformances, product deviations, CAPAs and the internal audit schedule.
  • The primary emphasis in this start-up is on New Product Introduction and the subsequent process of launching them in the market.
  • Ensured adherence to all requirements of ISO 13485 and 21 CFR Part 820.

Senior Engineer, Supplier Quality Compliance

Stryker Instruments
04.2016 - 07.2018
  • Managed challenging vendor relations and acted as mentor to junior team members in my role as senior engineer.
  • Updated senior management weekly and monthly on the groups projects, as well as reported key site vendor metrics
  • Partnered with R&D and Medical Team to created Health Hazard Evaluation reports for non-conforming supplier products when deemed necessary.
  • When required, I was accountable for implementing a Global Hold on product
  • This role also required me to support the SQE group with regards to technical knowledge
  • This frequently required me to spend extended time at key suppliers using 6 sigma tools and practical experience to lead problem solving activity
  • I gave progress updates on this activity to VP and director level management
  • Key Activities Supporting group knowledge in technical areas, specifically in relation to manufacturing and non-destructive testing
  • Supporting supplier audits and reviewing corrective actions to assess mitigations for suitability
  • Worked with suppliers to implement changes to increase productivity and reduce costs
  • Participated in supplier audits, giving guidance on special processes or as an active auditor preparing audit reports
  • Completed pre-audit assessments on suppliers and worked with vendors on their SCA (supplier corrective actions)
  • Led a cost saving project which resulted in a 50% reduction in product going on hold at incoming inspection
  • Managed the CAPA’s and NC’s with suppliers in relation to non-conforming product and liaised with R&D to establish associated risks

Quality Team Leader Global Supply Chain

Depuy Johnson and Johnson
06.2013 - 04.2016
  • Reporting to senior and Director level management regarding the design and implementation of Global quality initiatives
  • I was responsible for ensuring compliant solutions to project specific and day to day global shipping challenges
  • The Global Supply Chain was subject to two BSI audits, one FDA and one JJRC (J&J auditing body) audit with no observations
  • I had quality compliance responsibility for all Supply Chain CAPAs and NC’s, both that they met the required standard and that they were closed in a timely manner
  • Organisational Interfaces: All DePuy World Wide facilities, WW Regulatory Quality, Operations and Global Supply Chains
  • Distribution Centres, Tingley Leeds, Warsaw U.S, EDO Belgium and RDC Singapore
  • All GO Franchises Mitek, Spine, DePuy, Synthes and Codman
  • Key Activities Quality lead for the introduction of a new J&J distribution facility in Singapore
  • Quality lead for the introduction of systematic process solution for managing multi-variant products in Depuy
  • Quality lead for the transfer of the ERP systems from JDE XE to JDE 8.12 in the European Distribution Centre
  • I led an initiative to create a worldwide Defect Library for use in all J&J global distribution hubs
  • Responsible for managing the FMEA teams with individuals in Belgium, Singapore, US, Canada and India
  • This required strong Project management skills, compliance awareness and the ability to influence without authority
  • Managing the preparation of the DePuy Synthes Joint Reconstruction Executive Management Review
  • For two 3 month periods I back filled the Global Supply Chain Quality Manager and reported directly into the Quality director
  • Represent Quality and ensure effective and timely closure on all NC, CAPA, Failure Investigation Reports, PRA/HHE and Close Call Investigation for GSC business
  • Responsible for managing global stop shipments for distribution compliance issues

Senior Quality Engineer

DePuy (Johnson and Johnson)
02.2010 - 06.2013
  • Responsible for all DePuy Cork manufactured Hips and LCS femoral components
  • In this role I had primary QA responsibility for all products manufactured in this area, ensuring that they are manufactured in accordance with QSR/GMP, ISO 13485 and Medical Device Directive
  • Responsible for all Hips and LCS femoral components NC’s and CAPA’s
  • Key Activities Completion of Internal audits on all areas of the plant
  • Conducted QA investigations for the plant
  • Review and approval of ECO’s for all new drawings and drawing updates related to my area
  • Review and approval of ECO’s for all Risk assessments, validations, test methods; Standard work, Gauge R&R’s etc
  • Used my technical aptitudes and Six Sigma Skills to root cause problems and initiate corrective actions
  • Completing CAPA’s, disposition of NC’s and initiating PRA’s
  • Investigation of customer complaints and the review of returned product
  • Manage the daily activities, annual leave, cover, certifications and training of 3 quality technicians

XRAY and FPI Subject Matter Expert

DePuy (Johnson and Johnson)
03.2007 - 02.2010
  • In addition to my QA role I was also appointed Subject Matter Expert for the Cork Depuy site for X-ray and FPI inspection
  • I hold NDT level 2 certifications for both disciplines
  • I also support the backroom in this capacity during FDA and BSI audits on occasions when our Non Destructive Testing processes are being examined and from this have gained front room experience speaking to auditors

Quality Engineer, Foundry and Porocoat

DePuy (Johnson and Johnson)
03.2004 - 02.2010
  • During my time in the foundry I directed the preparation for two FDA Audits and two BSI Audits which required 'Front Room' interaction with auditors
  • I received my Six Sigma Green Belt certification and used the Six Sigma tools on a daily basis
  • Key Activities Ensuring the most efficient process yielding the lowest scrap rates for the lowest costs was in place
  • It was also my responsibility to raise CAPA’s/NC’s and implement corrective actions and where required and monitor effectiveness
  • Writing audit reports and preparing metrics for management review
  • Highlighting near misses, supplier/vendor issues
  • XRay and FPI inspections quality support
  • All day to day QE tasks, product on hold, NCs, Scrap costs compliance, GMP controls

Project Manager for Manufacturing Transfer

Stryker
07.2002 - 03.2004
  • Product transfers from U.S to Ireland sites

Education

BSC. (Hons) - Manufacturing Management

Manchester Metropolitan University
Manchester, England

Skills

  • Risk Management
  • ISO13485
  • ISO19471
  • AS9100
  • 21CFR Part 820
  • New Product Introduction
  • FPI and XRay NDT inspections
  • Six Sigma
  • Auditing
  • Medical Device Manufacture
  • Staff Management
  • Verbal and written communication

Certification

  • Six Sigma; Green Belt certified
  • Lead Auditor Certified (ISO13485 2016) – NSF Health Sciences
  • AS9100 Training - BSI
  • ASNT Level 2 Certified in FPI and Xray Non Destructive Testing (NDT)

Hobbies and Interests

  • Sea Kayaker
  • Amateur mechanic
  • Vintage motorcycle restoration

Affiliations

I am a Sea Kayaker and have competed in the Cork Ocean to City kayak Race. I am also an amateur mechanic and enjoy vintage motorcycle restoration

References

References available upon request.

Timeline

Quality and Regulatory Director Europe, UK and Asia

Tecomet
01.2024 - Current

Quality and Regulatory Manager & Management Representative

Tecomet
06.2019 - 01.2024

Quality Assurance Manager

OrthoXel
07.2018 - 06.2019

Senior Engineer, Supplier Quality Compliance

Stryker Instruments
04.2016 - 07.2018

Quality Team Leader Global Supply Chain

Depuy Johnson and Johnson
06.2013 - 04.2016

Senior Quality Engineer

DePuy (Johnson and Johnson)
02.2010 - 06.2013

XRAY and FPI Subject Matter Expert

DePuy (Johnson and Johnson)
03.2007 - 02.2010

Quality Engineer, Foundry and Porocoat

DePuy (Johnson and Johnson)
03.2004 - 02.2010

Project Manager for Manufacturing Transfer

Stryker
07.2002 - 03.2004

BSC. (Hons) - Manufacturing Management

Manchester Metropolitan University

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Alwyn Jennings