AMETEK, Inc. Director Quality in Middlefield, Connecticut
Responsible for maintaining and continuously improving the registered ISO 9001:2008 Quality Management System for all Zygo sites, and successfully transitioning to ISO 9001:2015. Also maintain ISO13485, FDA QSR 21 CFR 820, and FDA medical device registration at sites as applicable.
Travel to customers, suppliers and other ZYGO offices in support of the Quality function is required, approximately 15% travel.
Be responsible for all customer and registrar audits and quality-related issues. Represent the Company in reviews, presentations, supplier audits, and supplier days with customers. Develop the capabilities of the Quality Team to provide proper responses to customer quality issues, including proper training of customer personnel in industry standard optical inspection and quality standards.
Maintain our quality system and performance in line with the expectations of our major global customers in our diverse markets, including semiconductor, defense & aerospace, life science and medical, automotive, government research and space science, consumer electronics, and general industrial. Be well-versed in the quality expectations and requirements of customers in these diverse markets, maintaining and improving our quality management system as necessary to achieve and maintain preferred and/or strategic supplier status at these customers.
Proactively develop the Quality Team to provide leadership and continuous improvement throughout the organization and exceed customer quality expectations. Provide regular performance reviews, coaching and mentoring, and career development planning with exempt and non-exempt employees in the department. Determine the proper role of the Quality Team in product and process development, manufacturing engineering, and administrative functions. Provide Quality Engineering skills such as SPC, Six-Sigma and APQP in support of new product launches, process improvement and material quality.
Ensure the quality of incoming materials and services from our suppliers, including performing regular supplier audits to qualify/disqualify suppliers, and ensuring receipt of proper incoming inspection or quality documentation from suppliers. Assist Supplier Engineers in establishing standards for supplier performance; monitoring supplier compliance with Zygo standards and utilizing analytical and process tools such as Six-Sigma, SPC, and APQP. Maintain appropriate levels of data and manufacturing traceability to meet our various end markets, customer expectations and regulatory requirements. Implement and maintain an effective Dock-to-Stock program to eliminate unnecessary inspections. Provide the necessary support to procurement and engineering to achieve cost-down and other operational improvements through supplier selection and qualification activities.
Provide the Leadership Team with regular quality reports, updates, and recommendations as per the Quality Management System and ISO requirements. Ensure Quality Management System review meetings are conducted, and that quality related metrics, data, and customer feedback is provided to responsible managers. Working with the managers, assign individuals to implement corrective and preventive actions, and ensure that actions are completed in a timely manner.
Be a critical member of the Senior Leadership Team, participating in the development and implementation of the Company’s overall mission and strategy.
Lead and define, with various program and production teams, the Critical to Quality (CTQ) customer based performance needs. Translate those CTQ’s analytically and operationally through the Quality, Supply Chain, program and production teams. Ensure quality and process/method control procedures are developed and followed for material and product acceptance. Analyze data and specifications to ensure product compliance with requirements and standards. Propose improvements that will reduce the costs of poor quality. Represent the company and its quality system with customers, suppliers and employees.
Maintain control over and documentation of material under review. Coordinate the review of nonconforming material and assist in determining its disposition. Ensure that the proper nonconforming material documentation and process is followed throughout manufacturing.
B.S. degree in an Engineering discipline with an emphasis on Statistics, Mathematics, Optical, Mechanical or Industrial Engineering.
Additional training including certification in Six-Sigma, APQP, Lean Manufacturing or other Quality Engineering and Process Improvement tools is preferred.
Minimum 10 years' experience in Quality Control testing or Six-Sigma leadership, in a high-precision engineering based product manufacturing business including 2 or more years’ experience operating a QMS compliant with ISO-9001, and/or ISO-13485, and/or medical FDA QSR 21 CFR 820 regulations and 3 or more years' experience in supervision.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use of hands or fingers to handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is not exposed to weather conditions and the noise level in the work environment is usually moderate. ZYGO offers competitive salaries, a comprehensive benefit package and 401(k). EOE *APPLICANTS TO APPLY ON-LINE ONLY: Once you have completed your online application process, you will receive an auto reply email confirming your information has been received. Please do not contact the company directly.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Job ID #: 8874
Location: US - Connecticut - Middlefield
Functional Area: Quality Assurance
Division: MMA - Ultra Precision Technology
Position Type: Full-Time Regular
Education Required: Bachelors Degree
Experience Required: More than 10 years
Relocation Provided: Some Relocation May Be Available
Travel Percentage: 15