1. Robert L. MacKeen
36 Woodland Road
Billerica, MA 01821
781/974-2687 bmackeen@comcast.net
Dedicated Quality Assurance and Supplier Management professional with over 24 years of experience in the medical device,
commercial, aerospace and manufacturing industries.
Core Competencies:
ISO Management Representative Internal/Supplier Auditing
ISO 13485 Compliance Project Management
ISO 14971 Risk Management CAPA Process Management
Complaints Handling Regulatory Assistance
Supplier Quality Assurance Team Leader
Manufacturing Operations Facilities Management
Experience:
Director of Operations and QA/RA, Resonance Research, Inc. Billerica, MA 2011-Present
• Created, implemented and maintain all required documentation for ISO 13485:2012 compliance and obtained ISO
13485:2012 certification with TUV SUD America in May of 2012.
• Responsible for ensuring compliance of all departments to: ISO 13485:2003, MDD, FDA 21CFR 820, and
appropriate Regulatory Requirements.
• Prepare and conduct annual Management Review Meetings (which include CEO, and all VPs) showing objective
evidence that the company is meeting all the objectives of the quality policy.
• Obtained and maintain 60601-1 3rd
Edition Certification for the company’s Electronics Division
• Successfully coordinated and conducted negotiations with South Korea and Taiwan companies for whole body MRI
design projects.
• Managed all company projects to improve product integrity. Worked closely with Siemens, GE Healthcare, and
Philips to ensure successful installations at customer sites around the world.
• Facilitate weekly production meetings to maintain on time delivery of customer products
• Oversee day to day manufacturing operations, and Quality Assurance/Regulatory needs.
• Worked with internal engineering and external suppliers to identify, contain, and correct design issues.
• Evaluate and maintain supplier compliance to company standards through periodic onsite supplier audits. Prepare
audit reports based on results of assessment. Recommend corrective actions as required.
• Assisted the President/CEO with all marketing needs (e.g. Website design and maintenance, creating posters and
brochures for all conferences and trade shows)
• Facilitate and coordinate all departmental QMS and Regulatory training, increased QMS and Regulatory awareness
throughout the organization, and motivated employees resulting in improved adherence to company processes.
• Successfully negotiated, designed, and relocated the company to a new facility location at 6 Cook Street Suite 4,
Billerica, MA.
• Conduct annual employee performance reviews
• Created and lead Safety and ESD committees to ensure employee and product safety.
Sr. Quality Assurance Engineer, Aurora Imaging Technology, North Andover, MA 2006-2010
• Responsible for ensuring compliance of all departments to: ISO 13485:2003, MDD, FDA 21CFR 820, and
appropriate Regulatory Requirements.
• Provide QA/RA support as needed to address product and supplier issues.
• Prepare and conduct quarterly Management Review Meetings (which include CEO, CFO and all VPs) showing
objective evidence that the company is meeting all the objectives of the quality policy.
• Provide manufacturing support for all QA/RA compliance issues. Through training and education of manufacturing
personnel, reduced internal audit nonconformance by 42% in 2009 – the largest annual reduction in company
history.
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2. • Lead multiple projects to improve product integrity including failures due to poor design. Worked with internal
engineering and external suppliers to identify, contain, and correct design issues.
• Evaluate and maintain supplier compliance to company standards through periodic onsite supplier audits. Prepare
audit reports based on results of assessment. Recommend corrective actions as required.
• Increased supplier compliance by assisting external suppliers in creating more effective processes and methods
through training and education of supplier’s personnel. Reduced supplier product nonconformance by 32%,
exceeding the company’s goal for 2009 which was 25%.
• Managed and re-wrote the company’s internal auditing program. Recruited and trained internal auditors from other
departments involved in the design and manufacturing process.
• Managed and modified the company’s CAPA process to be more robust by improving the root cause analysis
process and by designing more effective and accurate data collection methods. Trained all appropriate staff in the
use of new evaluation materials. Monitored corrective actions for effectiveness after implementation.
• Provide QA/RA support to Product Development to ensure product compliance to company standards and created
and implemented a fully compliant Risk Management System per ISO 14971:2007.
• Facilitate and coordinate departmental QMS and Regulatory training, increased QMS and Regulatory awareness
throughout the organization, and motivated employees resulting in better adherence to company processes.
• Created and implemented a new process to identify customer complaints and to show the effectiveness of the
actions taken.
• Acting Compliance Officer assisting the V.P. of General Counsel with the implementation, maintenance, an auditing
of the Sales and Marketing code of conduct per Mass. Gen. Laws ch 111N and 105 CMR970.
• Created and lead Safety and ESD committees to ensure employee and product safety.
.
Project Engineer, AgaMatrix, Inc., Salem, NH 2005-2006
• Promoted to Project Engineer to provide a proactive interface between quality, marketing and the engineering staff
to ensure that new product deliverables were compliant to ISO 13485 standards and on time.
• Maintained documentation and communicated the project status of all R&D and Engineering projects to other
affected departments.
• Assisted in the off-site planning and development of future manufacturing facility.
• Proposed and implemented a new project database structure for all departments to better coordinate information
exchange.
• Acted as liaison between the CEO and the Director of Operations to communicate the requirements of a new R&D
laboratory to be built in a newly acquired facility, as well as the sourcing and acquisition of the required equipment
and supplies.
• Coordinated with R&D to determine alternatives for laboratory requirements where necessary to reduce costs.
• Attended training workshops for the maintenance and operation of newly acquired equipment.
Manager, Document Control, AgaMatrix
• Initially hired to implement a document control system for this medical device start-up company.
• Created, implemented and maintained change control procedures in compliance with FDA and ISO regulations.
• Defined product configuration and controlled manufacturing processes to ensure conformance to design,
regulatory, and customer requirements.
• Managed the operation of the document control center to ensure that all users had the latest revision of the
appropriate documentation.
• Assisted the QA/RA department with the creation and implementation of all required documentation for FDA and
ISO 13485 compliance.
• Coordinated and lead change order teams for the timely completion of change order processing.
• Provided training of document control procedures to all new and existing employees.
Sr. Quality Manager/Materials Specialist, Vortex, Inc., Peabody, MA 1999-2005
• Created, implemented and maintained all required documentation for ISO 9001:2000 compliance.
• Trained all company employees in ISO 9002:1994 and ISO 9001:2000 procedures and requirements.
• Managed customer ECOs including review, price and implementation.
• Conducted internal audits to ensure compliance to ISO 9002 requirements.
• Maintained and evaluated supplier compliance by conducting surveys and supplier audits as required.
• Additional responsibilities included purchasing and planning of raw material, hardware, and coordinated external
finishing and metal treatment services for the finished production of sheet metal products and assemblies.
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3. • Coordination and planning of special projects such as new product development, Vendor Managed Inventory,
Kanban, and was an active team member in the new department layout to maximize material flow throughout the
facility.
Quality Manager, Samtan Engineering, Malden, MA 1998-1999
• Created and implemented quality procedures in accordance with MIL-45208-A, aerospace and ISO9002:1994
requirements.
• Maintained documentation that was specific for the military and aerospace industry and our customer base.
• Created, maintained and updated job travelers, inspection records as well as managing all customer complaints
and performed corrective/preventive actions as needed.
• Participated in special projects such as marketing/advertising, waste removal, research of new equipment and
services.
Quality Manager, Advanced Engineering, Beverly, MA 1997-1998
• Implemented and maintained ISO 9002 certification.
• Conducted annual internal quality audits.
• Trained employees on the requirements for ensuring compliance to ISO 9002 standards.
• Maintained and updated manufacturing process sheets and inspection at all levels.
• Process owner for the Corrective/Preventive action process.
• Conducted first article, in-process and final inspection of all manufactured product.
Skills:
ASQ-MV Section 102 Leadership Board Member 2008-2011
2009 Certified CPA and First Responder
2008 ASQ Course Completion for Supplier Quality Management and Process Control
2008 ISO 14971:2007 Application of Risk Management to Medical Device
2006 ISO 13485:2003 Internal Auditing for FDA Regulated Industries
2005 Course Completion for Microsoft Project Workshop
2002 ISO 9000:2001 Training Workshop 2002 TUV America
1997 ISO 9002 Training Workshop – Ray Wilder Associates
Software Applications:
Proficient in the use of MS Office (Word, Excel, Access, Outlook, Project, PowerPoint, Visio)
Various MRP systems (MS Great Plains, DBA, MAX, Synergy); (Microsoft Dynamics)
Various photo editing applications (Adobe photo, MGI Photo Suite)
Adobe Acrobat
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