Vacancy expired!
About DEKA For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Housed in the largest industrial complex of its time, the historic Amoskeag Millyard, DEKA employs a team of over six hundred professionals, whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. About the role We are seeking a Quality Systems Manager to provide Quality Systems management and strategic direction for the development and manufacturing activities for some of the world?s most innovative products. This is in an effort to ensure compliance with FDA QSR, ISO 13485, and other applicable global quality requirements as well as alignment with company objectives and standards.This position reports to the Head of Quality. He or she will assist with directing development, implementation and maintenance of the company's Quality System, including Product Realization, Design and Document Change Control; Risk Management, Management Reviews, Quality Systems Training, CAPA, and Manufacturing Quality. What will you do?
Work as a team with Engineering, Manufacturing, Human Resources, and Regulatory Affairs to support and accomplish company objectives in conformance with all appropriate regulations and quality standards
Define and implement continuous improvement processes to improve operational efficiency and effective quality systems aligned with FDA and global regulatory requirements
Assist with the Management Review process, including identifying and maintaining metrics measuring the company?s adherence to the Quality Policy and Quality goals and objectives
Develop and implement short and long-term quality plans to support individual projects and the company as a whole
Drive state-of-the art methods in document and design controls and manufacturing quality assurance
Develop and deliver training programs at the quality system level and product development levels
Assist with CAPA and the internal audit program
Administer and maintain quality assurance procedures to ensure processes and products are in compliance with applicable quality standards and regulatory requirements
Maintain a knowledge base of regulations, corporate policies, best practices and standards to ensure continued and ongoing compliance with applicable quality standards and regulatory requirements, and conduct appropriate planning and quality system updates as required to maintain compliance
What do you need?
BS in engineering or similar technical field, and the ability to understand and appreciate advanced technology
5+ years QA leadership experience in a regulated product development and manufacturing environment (e.g. medical, FAA or military)
Working knowledge of QSR?s Part 820, ISO 13485, and MDD
Demonstrated ability to work effectively with US FDA and other regulatory agencies
Strong writing skills, especially with technical documents and quality system procedures
Excellent interpersonal communication skills
Proven analytical and complex problem solving skills
An understanding of the principles of configuration management and document control
Track record of measureable, operational improvements to Quality Systems related functions
The ideal candidate is able to engage both in extreme details and high-level strategy simultaneously
A working knowledge of quality improvement tools and techniques. Certification as a ASQ Certified Engineer, Six Sigma/Lean Black Belt or equivalent desirable
