QA Compliance Supervisor

Stevanato Group S.p.A. • Ontario, CA

3d • $100,000 - $140,000 • Onsite

About The Position

The QA Specialist is responsible for the supervision of the QA Staff and Document Control.

Requirements

• Bachelor's degree (B. A.) from four-year College or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
• Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Knowledge of Microsoft Excel Spreadsheet software.
• Knowledge of Microsoft Word Processing software.
• Ability to read and interpret blueprints, including geometrical dimensioning and tolerancing, and quality instructions.
• Working knowledge of material compliance regulations (e.g., REACH, RoHS, Prop 65).
• Strong understanding and application of statistical concepts and process control techniques.
• Demonstrated ability to collaborate effectively across cross-functional teams in a fast-paced manufacturing environment.

Nice To Haves

• ISO 13485:2016 trained auditor or certified auditor

Responsibilities

• Provide daily supervision, leadership, and operational direction for both Quality Assurance and Document Control personnel.
• Review and approve QMS documents, SOPs, and quality records to ensure compliance with internal controls and applicable standards (e.g., FDA, GMP, ISO 13485).
• Plan, schedule, host, and lead internal and external quality audits; drive audit findings through to closure via CAPA management.
• Lead and govern the Change Control and CAPA processes, including facilitating Change Control Board (CCB) and CAPA Board meetings.
• Review and approve material compliance declarations (e.g., REACH, RoHS, Prop 65) and provide technical/regulatory support as needed.
• Develop, conduct, and maintain site-wide GMP and quality system training programs for personnel.
• Oversee the non-conforming material (NC) area, approve Material Review Board (MRB) disposition decisions, and perform system holds or transfers.
• Support as needed on managing the Return Merchandise Authorization (RMA) process in coordination with complaint handling, investigations, and scrap activities.
• Collaborate daily with QC Management and internal departments. Interface with internal departments, suppliers, vendors, and customers; manage customer-facing quality agreements, questionnaires, and international regulatory documentation.
• Analyze quality metrics and trends to drive root cause investigations, track Quality Objectives (KPIs), maintain scorecards, and report outcomes to management.
• Coordinate departmental readiness for Management Review meetings, including KPI compilation and reporting in support of the Management Representative.
• Coordinate equipment calibration schedules with external vendors and monitor metrics to ensure tool and spare instrument availability.
• Oversee quality record retention, archive monitoring, and purging; provide backup support for Document Control (e.g., CoC issuance, lot folder closure).
• Interacts with and supports the entire Quality Department in daily continuous improvement activities.
• Directly supervises 3 employees in the QA department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager