Director, Quality Systems (Remote)

Isomedix Operations Inc. (US)•Northborough, MA

13h•$144,500 - $187,000•Remote

About The Position

The Director, Quality Systems is responsible for leading, planning, developing, and directing quality operations policies, programs, initiatives, and overall execution of the STERIS QMS within multiple facilities spread across geographical regions and countries. This position is fundamentally responsible for quality system execution and compliance within a complex network of technologies/modalities that operate within a heavily regulated environment and serve a diverse Customer-base with significant variance in product mix. The Director, Quality Systems has ultimate decision-making authority over the release and shipment of all product processed and laboratory results within their respective facilities. The Director’s decision-making authority also extends beyond product and laboratory sample release to matters involving Regulators and Customers. The Director accepts the responsibility and risk for processed products and samples tested as being in compliance with all regulatory and company standards, including 21 CFR Part 820, Part 211, Part 1271.150, Part 211, ISO 11135, ISO 11137, ISO 13485, ISO 17025 and other country-specific standards and regulations. The Director, Quality Systems leads teams of Senior Quality Managers, Quality Managers, Analysts/Engineers, and Technicians responsible for product quality, product release, supplier quality, continuous improvement support, technical support/technical guidance, and quality system execution. Leadership responsibilities extend to ensuring all quality operations goals, objectives, strategies, and tactics align and promote growth, operational excellence, Customer focus, and leadership excellence. The Director is a member of the AST Management Team and serves as the Management Representative for their respective facilities. In this capacity, the Director is expected to make an essential and active contribution to the overall performance of AST by evaluating the performance of production and quality system processes to improve exiting methods, process, and operations. This is a remote based role. While not required, candidates who live near a STERIS Advanced Sterilization Technologies (AST) location are preferred. Up to 50% travel.

Requirements

Bachelor’s Degree (engineering-based or science discipline).
Minimum 10 years of quality system and medical device and sterilization experience with increasing responsibilities leading quality systems and process improvement efforts.
Exceptional leadership manifested through organizing and motivating their teams toward respective goals by employing hands-on management.
Minimum 7 years direct supervisory experience.
Minimum 2 years’ experience overseeing quality systems and process improvements for multi-site locations, ideally locations in different countries.
A solid quality foundation indicated by a demonstrated understanding of lean, quality system and product/process improvement methodologies.
Solid business acumen and proven ability to build and lead process and improvement strategies and results.
Strong expertise in analytical methods, quality systems, and continuous improvement methods.
Excellent interpersonal, as well as verbal and written communication skills in order to develop and maintain rapport and effective internal and external relationships to support business success.
The ability to work hard and deliver results under pressure, as well as the willingness to address and shift priorities in rapidly changing environments.
Excellent problem-solving skills.
Focus on identification of potential issues and continuous improvement.
Experience working on cross-functional teams and on own initiative.
Demonstrated excellent organizational, oral, and written communication skills.
Ability to effectively read, write and verbally communicate in English.
Ability to work independently under general guidelines and supervision.
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, PowerPoint, and Visio.
Ability to influence people in the opinions, attitudes or judgments to generalize, evaluate and decide to adapt to demanding situations.
Normal hearing range sufficient to hear alarms, bells, horns, etc.

Nice To Haves

Experience in medical device industry

Responsibilities

Lead and direct Quality Managers and their staff to ensure QMS activities across their multiple facilities are consistent with Advanced Sterilization Technology (AST) goals and objectives. This is accomplished through systematic identification of opportunities for improvement and the diligence to ensure actions required as a result of audits, nonconformance, system deviation, Customer concerns and complaints are responded to timely and in a manner that meets the requirements of the QMS, regulations/standards and AST objectives.
Lead all regulatory authority inspections in assigned facilities to ensure investigator requests are met in a timely manner with the highest level of professionalism. Responsible for any remediation required as a result of an inspection immediately with a corrective plan to first direct the timely implementation at the inspected facility followed by a comprehensive assessment of the global facilities to identify and correct systemic findings.
Create and critically assess the impact of QMS procedures, global work instructions, and local work instructions on the daily operations of the facilities. Working alongside Quality & Regulatory Compliance and Operations management, identify opportunities for improvement and efficiency while ensuring the spirit of the regulations that govern AST are never compromised.
Direct large, cross-functional, and often global programs in support of Quality Operations and AST initiatives. by developing thorough and thoughtful control plans with repeatable and sustainable actions to be implemented in all facilities within their respective zone and globally.
Resolve escalating quality operations problems/concerns with site Quality Managers/Regional Quality Managers and others including vendors, Customers, Operations and Regulators requiring the ability to manage complex relationships with key stakeholders.
Analyze, evaluate, and present performance metrics concerning execution and performance on the QMS to Senior Leadership and Executive team. Support Senior Leadership and Executive team in establishing strategies designed to align and effectively execute on operations, quality system, commercial and Customer requirements.
Ensure that their respective facilities maintain and improve operational and quality systems to remain in a state of compliance to applicable ISO, Regulatory Agency and Customer regulations and standards. Must maintain an expert knowledge of applicable regulations and standards.
Lead by coaching, managing, motivating, and monitoring Quality Managers and their staff as needed through ongoing performance feedback, formal reviews and development initiatives which target individual strengths and weaknesses while delivering business results.
Responsible for ensuring timely and effective integration of the STERIS QMS into site expansions and acquisition.
Oversee the development of proposed quality budget in respective facilities and resource needs; monitor expenditures through oversight and establishment of appropriate controls and spending expectations.
Maintains professional skills, knowledge, and abilities by attending educational workshops, reviewing professional publications, and participating in professional societies.