Quality Management Systems Associate Manager

Creation Technologies•Rochester, NY

8h•$70,000 - $95,000

About The Position

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. This role facilitates the overall Quality Management Systems (QMS) activities under direction of the Quality Leader or Quality Director, ensuring they meet regulatory, Creation and Customer expectations. Focus on the continual improvement of local Regulatory maturity. Responsible for overseeing and supporting aspects of site Quality Management System processes and ensuring site/sites are compliant and prepared to represent their local execution of the QMS. This would include supporting preparing for site regulatory and certified registrar needs including matters related to Medical Device Products, including facilitating FDA and certification preparedness and interactions until resolution. This position works in collaboration with the Site functional Leaders to ensure QMS processes meet the regulatory requirements. Responsibilities may also include supporting site annual Cost of Poor Quality (COPQ) waste reduction projects, including inspection, defect and rework reduction and Yield improvement projects. Business process owner for site QMS elements such as Corrective Action/Preventive Action (CAPA) and internal Audit processes. Collaborates across Site functions (sales, manufacturing, quality, logistics, engineering, etc.) as well as interacting with the Global Quality organization. This role calls for a unique blend of quality system management experience, collaboration and training sensibilities, project management skills, and business acumen.

Requirements

A bachelors or higher degree or 6-8 years' experience in any combination of Quality Systems and regulatory affairs required.
Expertise in FDA Device Good Manufacturing Practices (GMP), ISO 13485, 9001, and AS9100, standards.
Proven experience in leading projects, performing quality audits, and authoring procedures.
Proficiency in quality data analysis tools and investigation methods.
Experience in Medical, Aerospace/Defense, or Automotive industries required.
Background in large or mid-sized electronics manufacturing preferred.
US Citizen or lawful permanent resident or a protected individual under the Immigration and Naturalization Act is required.
Proficient in use of Lean and Six Sigma, or other process improvement methodologies and quality tools (i.e. Pareto Chart, Histogram, SPC, Flowchart, etc.).
Proficient in use of PFMEA, Control Plans, Measurement System Analysis, APQP and PPAP.
Proficiency in interpretation of assembly prints and drawings.
Excellent English communications skills (verbal and written)
Able to effectively present information to top management, public group and/or customers.

Nice To Haves

Preferred certifications: Six Sigma (Green/Black Belt), American Society of Quality (ASQ) CMQ/OE, CQA, RAPS, Project Management, or Lead Auditor.

Responsibilities

Support site teams in continuous improvement and maturity, focusing on assigned Business Process Owner (BPO) areas.
Provide coaching and mentoring to ensure success in execution and audit readiness.
Engage with FDA and regulatory agencies, representing the organization in compliance activities.
Write effective CAPA responses to regulatory findings and lead improvements in QMS infrastructure for FDA/ISO requirements.
Facilitate training sessions for audit preparedness and ISO certification support.
Manage and improve quality metrics, including inspection reduction, defect elimination, rework reduction, and yield improvements.
Collaborate with cross-functional teams to develop capabilities, address challenges, and drive strategic initiatives.
Communicate technical information clearly to senior management, customers, and teams, influencing decisions and aligning goals.
Lead without direct reports, fostering collaboration, team building, and professional growth through mentorship.
Manage multiple projects, ensuring timely and accurate delivery while meeting firm deadlines.
Demonstrate business acumen with negotiating skills, the ability to handle difficult conversations, and fiscal responsibility in budget planning.
Exhibit high energy, organization, and attention to detail, driving alignment with organizational objectives and industry best practices.
Work autonomously, escalating issues as needed and balancing operational needs with financial constraints.
Ability to travel occasionally (2-3 times per year) domestically and internationally
Other duties and responsibilities as assigned