EPTAM Precision Plastics is looking for a Quality Manager to join our team in Northfield, NH.Join us as we create devices being used in all facets of the medical industry. Our parts are seen in the following areas including; biopharma, molecular diagnostics, robot assisted surgeries, implantable devices, and much more. We look forward to sharing more about how we help the world around us. Since its founding in 1981, EPTAM Precision Plastics, a Northfield, New Hampshire-based company, has been a leader in solving the most difficult challenges in plastic component manufacturing and CNC machining. EPTAM Plastics is the largest North American manufacturer of machined plastic products and assemblies. The professional team comprises over 285 engineers, production specialists, and dedicated quality control experts. The FDA-registered, ISO 13485 center also features comprehensive automated inspection. With 10+ probe and vision coordinate-measuring machines (CMM), EPTAM Plastics can support you with metal-to-plastic conversions, material design support, and design for manufacturability using FMEA practice. EPTAM Plastics is the leader in complex multi-axis plastic machining using 3-, 5-, and 7-axis machine centers, CNC turning, Swiss, milling, routing, sawing, and drilling. We believe that the key to our success is combining world-class machining with our world-class metrology. Partnering those components with our proven processes and exceptional team help us bring the best to our customers and the world. EPTAM Solutions our parent company, with locations throughout the US, is at the heart of manufacturing. We have manufacturing locations nationwide. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Benefits Include:
- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Re-imbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
POSITION SUMMARY: The Quality Manager is primarily responsible for the following:
- Provide leadership in the development, implementation, communication and maintenance of the facility Quality Management System policies and procedures.
- Achieve and maintain a high degree of joint ownership of quality and compliance strategies with all the major operational stakeholders in the organization, and
- Address Quality and associated regulatory requirements in an effective, timely and responsible manner.
ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Formulate and manage the development and implementation of Quality goals, objectives, policies, procedures, and systems.
- Assist in all areas of the facility with interpreting and using the Quality Management System and the applicable Quality Management System standards.
- Quality project lead for cross-functional projects including determining Quality timelines, plans, and position strategies.
- Manage and maintain the facility's Internal Quality audit program and assess improvement initiatives resulting from all Quality Audits - internal and external.
- Report on a timely basis to the Management Team on the performance of the Quality Management System, any non-compliance issues, and recommended actions.
- Manage key Quality Management System activities including, but not limited to internal auditing, corrective and preventive action system, and complaint handling.
- Schedule and conduct periodic Management Reviews
- Lead the organization toward continuous quality improvement through implementation of common quality improvement tools such as SPC, FMEA, fishbone diagrams, etc.
- Respond to customer Non-Conformances.
- Manage and monitor all inspection, calibration, and gaging processes and activities.
- Recommend and manage inspection improvements.
- Coordinates with customer's auditors and ensures the execution of corrective action and compliance with the customer's specifications.
- Responsible for hiring, training, performance management and career development for all direct report team members.
OTHER RESPONSIBILITIES:
- Represent the company, as required, during customer, internal and ISO audits, as well as FDA inspections.
- Attend and actively participate in daily Gemba walks when possible.
- Foster and uphold the core principles of the organization, centered around the well-being of Employees, Customers, and Stakeholders, to establish a workplace culture that excels in achieving exceptional employee engagement.
- Understand the sensitivity of the data handled by the systems under your control and take appropriate measures to protect it.
- Ensure compliance with national and international standards and legislation.
- Promote quality achievement and performance improvement throughout the organization.
EDUCATION AND EXPERIENCE:
- EDUCATION: Bachelor's degree with a major in business, quality, applied science, or an engineering field.
- EXPERIENCE: Five (5) years quality assurance and/or quality control management, or ten (10) years extensive quality assurance and/or quality control experience, including supervisory responsibilities, preferably in a manufacturing environment. Experience with Quality Management Systems and Quality System Audits.
- LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: Professional certifications desirable (including, but not limited to ASQ Quality Manager-CMQ/OE, Quality Engineer-CQE, Certified Quality Auditor-CQA)