Director of Quality

Creation Technologies•Rochester, NY

3d•Onsite

About The Position

The Quality Director provides leadership to Quality Engineers and support Quality Staff, in addition to cross-functional leadership or direct oversight where the size and scope of the site is above average. This role serves as a subject matter expert (SME) with a Quality focus across applicable disciplines, operating at an operational level with site-focused project development. Responsibilities include influencing and resolving escalations with customers up to and including Tier 1 levels, as well as providing strategic, technical, and project management support at the site level for Quality and other functional initiatives. The goal is to reduce the cost of poor quality (COPQ) and optimize Quality Management System (QMS) processes.

Requirements

Bachelor’s Degree required in Quality or Technical Discipline
Minimum 10 years of relevant Quality experience in electronics manufacturing or Medical Device/A&D environments
At least 5+ years in Quality management/leadership roles.
Expertise in ISO 9001, ISO 13485, AS 9100, and FDA 21CFR820 compliance.
Proficiency in Lean methodologies, continuous improvement, and Statistical Process Control (SPC) implementation.
Advanced knowledge of Microsoft (MS) Office Suite, especially Excel.
Strong problem-solving skills with experience in systemic issue resolution, root cause analysis, and corrective/preventive actions.
Excellent communication and presentation skills adaptable to various organizational levels.
Ability to manage multiple projects and deliver results on time in a matrixed, global environment.
Proven leadership in fostering collaboration, coaching, and mentoring teams.

Nice To Haves

Master's Degree in related discipline preferred
Lean Six Sigma Belt and/or American Society of Quality (ASQ) certifications (e.g., CQE, CMQ/OE) preferred.

Responsibilities

Lead and manage Quality/functional personnel to meet site and, where applicable, regional goals and targets across functions.
Act as a decision-maker for technical teams, prioritizing customer interests while collaborating with financial teams on talent assessment and key quality initiatives.
Provide guidance and mentorship to site-level Quality team members, advising on activities that affect operational, internal and external product and customer outcomes.
Act as an SME across multiple Electronic Manufacturing Service (EMS)/QMS/assigned functional areas, offering credible support to customers and suppliers to ensure projects and products meet quality and manufacturing standards.
Influence site business improvements, regulatory compliance, continuous improvement efforts, and customer support initiatives.
Maintain and enforce control over Regulatory Agency requirements (e.g., UL, FDA, FM, CSA) and certifications/standards (ISO 9001, ISO 13485, AS 9100, IPC workmanship standards).
Apply Lean Manufacturing and Six Sigma methodologies to drive process improvement and efficiency.
Manage Key Performance Indicator (KPI) metrics such as customer complaints, factory yields, and supplier acceptance rates.
Foster collaboration with site Quality leaders, regional Quality leaders, and external stakeholders to resolve issues and promote innovation.
Contribute to site budgeting processes, continuous improvement initiatives, and site personnel performance, including headcount modelling.
Serve as a member of the Site Leadership Team, aligning with the organization’s vision and strategy.
Some travel between business units, customers, and suppliers as required.
Other duties and responsibilities as assigned.