IDEX Director of Quality Assurance & Regulatory Compliance in Middleboro, Massachusetts
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.
IDEX Health & Science LLC-(Middleboro)
Director of Quality Assurance & Regulatory Compliance
Director of Operations of IDEX Health and Science, Middleboro
SCOPE OF THE ROLE
The QARA Director will work independently and must drive initiatives through earning credibility throughout each function of the organization. S/he will manage projects through both direct and indirect, or "sphere-of-influence," forms of management.
KNOWLEDGE, SKILLS & REQUIRED ABILITIES
Achieve department goals and metrics in line with yearly business goals as they relate to Quality, On Time Delivery, Working Capital, Material Productivity, and Supplier Management.
The QARA Director is responsible for overseeing the Quality Management System in compliance with ISO13485 and ISO9001 along with Inspection, Regulatory Compliance, 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 Middleboro ISO Management Representative. These responsibilities include:
Ensuring the processes needed for the quality management system are established, implemented, and maintained.
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 to create and implement organizational policies, standards and procedures to comply with applicable regulations and standards.
Responsible for developing and maintaining relationships, as necessary with notified bodies, registrars, customers quality representatives and suppliers.
Manages non-conforming material's review board (MRB) system including WIP rejects and incoming materials.
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.
Interface with multiple departments, levels of management, customers, and suppliers.
Complete and disseminate metric reports.
Maintain dual ISO9001 and ISO13485 certification, perform audits, and work with auditors to improve processes.
Lead special projects as assigned.
Participate in rapid improvement events and other continuous improvement activities.
Support the Management of Daily Improvement (MDI).
Responsible for the overall management of the Quality Department, including staff supervision.
Bachelor’s degree in Engineering or other technical discipline preferred.
Experience working in a manufacturing environment required. Injection Molding and/or Automation experience is a plus.
7 years of progressive experience in Quality Assurance and a minimum of five-year management/supervisory experience in a Quality role.
Comprehensive knowledge of quality assurance practices and processes.
Excellent knowledge of 21 CFR Part 820, CFR Part 11, REACH, RoHs, European Manufacturing Directives and other applicable regulations, ISO 9001:2015 and ISO13485:2016.
Internal auditor and continuous improvement experience required.
Excellent written/verbal/teaching skills with attention-to-detail.
Demonstrated PC, Microsoft Word, Excel, and Access database skills.
Must have a working knowledge of quality programs, with experience in a variety of measuring/inspection instruments, auditing processes and closed loop corrective action programs.
Ability to travel up to 25% to customer, supplier, and intercompany sites.
ABOUT IDEX HEALTH & SCIENCE, LLC
IDEX Health & Science is the global leader in life science fluidics, microfluidics, and optics, offering a three-fold advantage to customers by bringing optofluidic paths to life with strategic partnerships, solutions, and expertise. As one of the few companies in the world with component, sub-system, and application level experts, IDEX Health & Science helps instrument developers solve the most demanding fluidic and optical challenges in a wide array of applications. With over 1,200 employees around the world, we believe partnership will change the way the world innovates, leading to new technologies that improve our health, protect our planet, and enrich our lives. For more information visit: www.idex-hs.com
ABOUT FLUIDICS AND MICROFLUIDICS TEAMS
Our fluidics team is located across Oak Harbor, WA, Rohnert Park, CA, Bistol, CT, and Middleboro, MA. At IDEX Health & Science, we don’t just build components; we also create innovative solutions that maximize performance and enable complete optimization of the fluidic pathway. Product lines include: Column Hardware, Degassers, Fluidic Connections, Manifolds, Pumps, Pump Components, Sensors, RI Detectors, and Valves.
Our microfluidics team is located in Wallingford, CT, and Zweibrücken, Germany. As the number one provider of microfluidic consumables across the globe, we are ready to help you solve the next big thing with the broadest portfolio of capabilities. Product lines include: Microfluidic Consumables, Sample-to-Answer Solutions, Supporting Labware.
ABOUT IDEX CORPORATION:
IDEX Corporation, based in Lake Forest, Illinois (suburb of Chicago), is a $2.2 billion engineered solutions company. The company operates globally across a variety of markets, including: Agriculture, Analytical Instrumentation, Food and Beverage, Chemical Processing, Clinical Diagnostics, Custom Precision Dispensing, Fire & Rescue, Fuels & Energy, Medical, Sanitary, Semiconductor and Water.
These businesses comprise a strong platform for growth at IDEX. Chairman & CEO, Andrew Silvernail, is committed to strategic (organic and acquisitive) growth across the business. With a strong balance sheet, IDEX is in a very good position to make strategic acquisitions going forward. At the same time, IDEX is committed to finding value and has no interest in overpriced acquisitions for the sake of top line growth alone. As the company continues to evolve and grow, it will be an exciting and rewarding environment for the strategic, results-oriented and emotionally intelligent business leader.
The information on this job description has been designed to indicate the general nature and level of work performed by employees within this role at the Middleboro facility of IDEX Health & Science. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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 (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.