175 Freshwater Boulevard
Enfield, CT 06082-4444
Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample, and cell handling in laboratories worldwide. Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermentors, bioreactors, CO2 incubators, shakers, and cell manipulation systems. Consumables such as pipette tips, test tubes, microtiter plates, and single-use bioreactor vessels complement the range of highest-quality premium products.
|Salary Range:||Location:||To Commensurate With Experience||ENFIELD CT|
|Job Type:||Category:||Full Time||Executive|
|Education Level:||Work Experience:|
ISO 9001 - Preference: Nice to have|
Ability to travel - Preference: Nice to have
|The Executive Director/Director of Quality Management & Regulatory Affairs at Eppendorf – Enfield facility will lead the Quality and Regulatory function in Enfield, CT, and will be responsible for establishing, implementing, and continuously improving a best-in-class local quality & regulatory management and assurance program aligned and consistent with the Eppendorf AG Corporate guidelines.|
Some of the exciting initiatives you would lead as part of our team:
Establish and champion a strong culture of bringing focus to Cost for Poor Quality through effective communication, training and continuous process improvement with our manufacturing teams and all other stakeholders.
Implement a balanced scorecard that encompasses both operational and financial metrics internally as well as with suppliers for supplier quality, audits, and inspections
Develop, improve and execute the EMC Quality Management (QM) System (ISO 9001 and 13485) according to Eppendorf AG Matrix QM system including incorporation of global standards into Local guidelines
Establish and lead the quality management reviews at EMC, implementing the necessary changes to continuously drive systems and process improvement throughout the organization.
Collaborate with R&D leadership and teams to ensure systems and processes are developed and implemented to ensure quality is designed into new products.
Develop and drive Quality initiatives that effectively address manufacturing and product quality issues. Support manufacturing teams in resolution of customer quality problems related to assembly, process and product function by driving robust corrective actions and change in processes.
Establish quality systems and directives for manufacture of Bioprocess Bench/Pilot Production equipment and consumables such as product & process validation, cGMP documentation and genealogy support, Pressure Equipment Directives (PED), and ensure necessary compliance.
Develop, implement, and improve regulatory compliance of products, processes and documentation according to system specifications as well as current global directives.
|Our ideal candidate will bring:|
Bachelor’s Degree in Engineering required (preference for Electrical, Mechanical, or Chemical); Masters or other technical graduate degree highly preferred
15 or more years of progressive experience in Quality Management required (including seven or more years in the manufacturing quality environment required)
Seven or more years of experience in progressive leadership roles required
Experience in a high-level quality leadership role (Director, Sr. Director or equivalent) required with proven ability to bring Systems Level Thinking and Process driven implementation across the organization.
Proven track record of leading effective change initiatives and quality management development
Work experience in laboratory equipment manufacturing (Life science equipment such as centrifuges, shakers, freezers, bioprocess reactors and controllers) environment preferred
Extensive experience with quality techniques: Design and Process FMEA, SPC, etc.
Well versed with regulatory standards such as IEC 61010, ASME, Pressure Equipment Directive (PED)
Six Sigma, Certified Quality Engineer (CQE), Certified Manager of Quality/Operational Excellence (CMQ/OE) certifications preferred
Ability to travel occasionally – domestic as well as international
If you are interested in this exciting opportunity please apply online at www.eppendorf.com
Eppendorf and all of its subsidiaries are equal opportunity employers. As such, it is our corporate policy to fill positions with qualified candidates regardless of the candidate's race, color, sex, age, religion, ancestry, national origin, citizenship status, marital status, sexual orientation, gender identity, genetic information, disability, pregnancy, military status, veteran status or any other protected group status.