Work closely with buyer/planners and suppliers to review supply needs and/or material problems. Recommend acquisition of new or replacement of equipment and tools to improve business performance or risk mitigation.
Review and sign off on engineering change notices, NCMRs, OALs, Variances, CAPAs and other quality documents.
Respond to customer complaints/input and act as a resource to Sales & Marketing Departments.
Manage cost improvement, risk reduction and quality improvement programs and establish policies and programs that foster communication, team building and motivate all employees.
Keep Director of Operations informed of unusual operating conditions. Submit a variety of reports relating to manufacturing activities. Prepare and submit operating budgets for approval.
Comply with GMP, ISO and OSHA regulations.
Set, motivate and develop team to to ensure flawless operation and continuous improvement mindset.
Knowledge, Skills and Abilities
Person that strives to understand the details of the area of manage.
Analytical mindset and can collect, analyze, present/communicate complex data concisely.
Ability with personnel management and team development and motivation.
Understanding of molding and automation processes is preferred.
A proven rack record of cost reduction and work simplification.
Creative individual who is able to communicate and coordinate good ideas through to implementation.
Ability to communicate well in English and Spanish, both orally and written.
In-depth understanding of equipment, equipment qualification and process validation.
Six Sigma Green Belt or higher certification is a plus. Solid understanding of lean tools.
Power user with Microsoft Software such as Excel, Microsoft Word, Power Point, PowerBI etc.
Thorough understanding of medical device manufacturing, especially as it relates to FDA and ISO 13485 manufacturing requirements
Experience
A minimum of 8 years experience in managing a manufacturing environment that is both labor and machine intensive.
Education
Engineering degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Material Engineering, Biomedical Engineering, Microbiology or similar
Master’s degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering is a plus.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com