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IDEX Director of Quality and Regulatory Compliance in West Henrietta, New York

If you’re looking for a special place to build or grow your career, you’ve found it. Whether you’re an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact.

With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses (https://www.idexcorp.com/our-businesses/business-segments/) around the globe, chances are, we have something special for you.

JOB TITLE: Director, Quality and Regulatory Compliance REPORTING TO: VP/General Manager – Life Science Optics LOCATION: West Henrietta, NY

ITAR/EAR CRITERIA:

These positions may require lawful access to ITAR/EAR controlled information and employees in this role will need to meet those requirements.

Requirements include US Citizenship or US Permanent Resident.

Who is IDEX Health & Science (IH&S)?

As a business unit of IDEX Corporation, IH&S has a long history of driving growth in life sciences and healthcare by embracing innovation and redefining the supplier-customer relationship. The work we do every day allows us to discover key insights and break new ground to create some of the most meaningful technologies that have a lasting impact on companies, industries, and society. One of business segments is called Life Science Optics and we are looking to add more talent to the team.

Life Science Optics (LSO):

Our newly opened Optics Center of Excellence in West Henrietta, NY , is a manufacturing and R&D focused team that sits at the leading edge of high-end optics for life sciences. Focused on assisting partners at every stage of the development processes, we invest in people and infrastructure to drive bold ideas and pragmatic solutions. With its optics-rich foundation of talent, universities, and supporting businesses, Rochester is the ideal location to elevate your career with fascinating work and endless opportunities.

Our formula for success is simple. We work hard to maintain a culture where you can own your work; you are encouraged to try new ideas in a collaborative environment; and you can apply your skillset to enable our clients to gain a competitive advantage in their own market. At IDEX Health & Science, you have the opportunity to work with a great group of people, mentor others, and build a great future.

SCOPE OF ROLE:

The Director of Quality & Regulatory Compliance is responsible for (1) providing strategic leadership in global quality, regulatory compliance and environment health & safety activities to ensure continual compliance to US / international regulations and standards; (2) providing strategic direction to the Quality Assurance, Manufacturing Engineering, and Operational Excellence teams; (3) providing strategic quality, regulatory compliance, and technical input to project teams on new product introductions; and (4) developing and presenting quality and regulatory compliance proposals to prospective customers. The position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies. This is the most senior Quality position and a critical member of the Life Science Optics Leadership Team.

ESSENTIAL DUTIES:

  • The Director Q&RC is responsible for the day-to-day activities of the Quality Assurance, Sustaining Engineering, Continuous Improvement, Environmental Health & Safety and facilities teams. Currently 40 team members

  • Achieve department goals and metrics in line with monthly and yearly business goals as they relate to Quality, On Time Delivery, Working Capital, Productivity, and Supplier Management.

  • The Director of Q&RC is responsible for overseeing the Quality Management System in compliance with ISO9001 along with Inspection, Regulatory Compliance (TUV, CDRH, ROHS, REACH, Conflict Minerals, WEEE, 21CFR, IEC 60825-1, and standard import/export regulations), Customer Returns, Supplier Quality and Document Control, design review and production support functions.

  • This position has the overall authority and responsibility as IDEX Health & Science LSO ISO Management Representative. These responsibilities include:

  • Ensuring the processes needed for the quality management system are established, implemented, and maintained in accordance with the most recent ISO 9001 requirements.

  • Periodic reporting to the top management on the performance of the quality management system and any need for improvement.

  • Ensuring and promoting the awareness of customer requirements throughout the organization.

  • Responsible for developing and implementing a continuous improvement program for the business to improve both manufacturing and business processes.

  • Responsible for driving the productivity initiatives of the business to improve labor, burden, and material efficiencies.

  • Responsible for providing technical support for the day-to-day manufacturing efforts of all product lines at the plant. Driving and improving factory overall efficiency metrics of first pass yield, cycle times, and uptimes.

  • Support operations management in assessing material and process defects in support of corrective action programs.

  • In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing, and supplier corrective actions.

  • Direct and oversee the Safety Programs for all Life Science Optics Sites and manage OSHA reporting

  • Direct and oversee the Environmental Health Policies/Procedures for all Life Science Optics Sites

  • Direct and oversee the facility preventative maintenance and improvement initiatives

  • Actively participate in the Management of Daily Improvement (MDI) at the site.

  • The Director Q&RC must drive initiatives through earning credibility throughout each function of the organization.

EDUCATION AND EXPERIENCE:

  • B.S. Degree required; advanced degree highly preferred.

  • Ten or more years in Quality and Regulatory related manufacturing operations management positions with progressively more responsibility.

  • Prior experience implementing and maintaining an ISO 9001 Quality Management System required – ISO 13485 experience is desired.

  • Black Belt level Six Sigma/Lean experience preferred.

  • Experience in low volume/high mix manufacturing required

  • Knowledge of GD&T is required, experience in optics manufacturing is preferred.

  • Demonstrated ability to achieve results in a cooperative, cross-functional, participative (e.g. matrix) environment.

  • Demonstrated effectiveness in motivating and executing against objectives, policies and procedures through team, including non-exempt associates.

  • Strong operational excellence background required

OTHER SKILLS and ABILITIES:

  • Demonstrated ability to understand, plan and execute dramatic change in manufacturing structure, systems and philosophy.

  • Ability to negotiate, cooperate and effectively interact with peers, superiors, team and vendors to achieve results.

  • Outstanding demonstrated verbal and written communication skills.

  • Good ability to use PC & ERP tools for communication, data extraction, and analysis. JDE knowledge a plus.

  • Ability to independently perform financial and operational assessments of new projects or systems and current activities using PC based software.

  • Previous experience organizing and driving effective daily management meetings through an organization

  • Must be able to travel to customer/supplier sites throughout the world.

IDEX Health & Science LLC., a Unit of IDEX Corporation is an Equal Opportunity Employer committed to workforce diversity.

Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world?

IDEX is an Equal Opportunity Employer and Affirmative Action Employer. IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws (Minorities/Females/Protected Veterans/Disabled).

IDEX (NYSE: IEX) is a company that has undoubtedly touched your life in some way. In fact, IDEX businesses make thousands of products that are mission-critical components in everyday activities. Chances are the car you’re driving has a BAND-IT® clamp holding your side airbag safely in place. If you were ever in a car accident, a Hurst Jaws of Life® rescue tool may have saved your life. If you or a family member is battling cancer, your doctor may have tested your DNA in a quest to find the best targeted medicine for you. It’s likely your DNA test was run on equipment that contains components made by our growing IDEX Health & Science team.

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