Description

The Manager, Quality, is responsible for overseeing and maintaining the Quality Management System (QMS) in compliance with ISO standards, FDA guidelines (as applicable), and customer requirements for Delphon’s Hayward facility. The Hayward facility supports the product realization activities of Gel-Pak, and TouchMark divisions. Gel-Pak develops and manufactures a family of elastomer-based carriers and films designed to provide maximum protection during the shipping, handling and processing of delicate devices. TouchMark provides high quality precision pad printing and manufacturing services to the medical device, diagnostics, and electronics industries. The Manager, Quality is responsible for developing and enforcing quality procedures, leading internal audits, managing the Quality team, and collaborating cross-functionally to drive continuous improvement. The Manager, Quality serves as the ISO Management Representative for the Hayward facility and ensures compliance with all applicable state, federal, and local regulations.

ESSENTIAL DUTIES AND RESPONSIBILITES

Responsibilities include but are not limited to:

• Ensure quality through oversight and guidance throughout design, development, and production.

• Conduct investigations into product and process non-conformances; oversee corrective and preventive actions (CAPA); maintain relevant documentation.

• Handle customer complaints inclusive of RMA (Return Merchandise Authorization), and SCAR (Supplier Corrective Action Requests) s; ensure timely resolution and effective communication with relevant stakeholders (internal and external).

• Maintain the ISO 9001 Quality Management System (QMS); lead internal audits and prepare for customer and regulatory audits.

• Ensure compliance with document control procedures; review and approve quality records and manufacturing deviations.

• Lead Material Review Board (MRB) and support failure analysis, FMEA (Failure Mode Effects Analysis), and risk assessments.

• Develop and maintain control plans, inspection standards, and calibration systems.

• Manage Hayward production employee training records, certifications, and training effectiveness reviews.

• Track and report KPIs, efficiency, and quality metrics.

• Collaborate with Engineering, Production, and Customer Service departments to drive continuous improvement.

• Ensure a safe and healthy work environment in accordance with Cal/OSHA and company safety standards.

• Support change control, Coordinate Measuring Machine programming, process capability studies, and Gage Repeatability and Reproducibility (GR&R).

• Participate in ISO management reviews, customer surveys, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and audits.

• Maintain EQMS (Enterprise Quality Management System), ERP (Enterprise Resource Planning) systems, and Quality department dashboards.

• Review gross margin impacts related to quality and efficiency issues.

• Oversee the daily activities of the department across both the day (6:30 am to 2:00 pm) and swing shifts (2:30 pm to 11:00 pm), including scheduling, training, and performance management. Be on-site from time to time during swing shifts to provide oversight and support. In the absence of the Quality Supervisor, be present on-site as needed to ensure support for both day and shifts.

• Oversee recruitment, training, and performance evaluation within the Quality department, contributing to the onboarding and professional development of the Quality team.

Requirements

ESSENTIAL EDUCATION AND TRAINING REQUIREMENTS

• Bachelor’s degree in engineering, Quality, or related technical field.

• 5+ years' experience in a quality or regulated manufacturing environment.

• 3+ experience working in a highly regulated industry. Medical device or semiconductor manufacturing preferred.

• Strong working knowledge of ISO 9001; working knowledge of ISO 13485. Familiarity with FDA Quality System Regulations is a plus.

• Strong working knowledge of MS Suite (Outlook, Excel, Word, PowerPoint specifically)

• Proficiency in ERP systems, EQMS, and basic working knowledge of CAD tools.

• Able to read, speak and understand English text, instructions, and diagrams.

• Strong leadership, problem-solving, and organizational abilities.

WORK ENVIRONMENT AND PHYSICAL DEMANDS

• Operates in both an office and manufacturing environment.

• Able to sit, stand, and walk within a confined manufacturing space.

• Able bend, twist, turn, reach, and lift to 50 pounds.

• Frequent use of computers, standard office equipment, and manufacturing-oriented measurement tools.

• Travel required for audits and customer visits will be infrequent, typically 10-15%.

• Maintain 1) reliable and safe transportation to Delphon facilities, customers and for other business travel, 2) valid State-issued driver’s license, 3) proper vehicle registration, and 4) State-required minimum automobile insurance coverage requirement.

This position is for direct hire only. However, staffing firms may express their interest in staffing this role in the future by clicking here