Manager, Quality - #1407536

Delphon


Date: 4 weeks ago
City: Hayward, CA
Contract type: Full time

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.

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Wound Care Physician or APP

AmeriWound, LLC, Hayward, CA
$215,000 - $225,000 per year
1 week ago
Wound Care Physician, Advanced Practice Provider – Hayward, CA AmeriWound affiliate, WoundMD Physicians CA, is hiring Physicians and Advanced Practice Providers, of most specialties, to provide wound care services in long-term care facilities. Whether you are looking to fill gaps in your current schedule or make a career change, this position will provide you the opportunity to enjoy an individualized...

Director of Business Operations, Clinical Operations (Office OR Remote)

Arcus Biosciences, Hayward, CA
3 weeks ago
Description The Director of Business Operations, Clinical Operations, is responsible for managing key business operations within the Clinical Operations department. This role includes overseeing and optimizing of critical business processes, including systems, related to clinical trial planning and execution, supporting inspection readiness, and training and onboarding for Clinical Operations. The Director will collaborate cross-functionally with internal stakeholders to drive operational...

Construction Materials Testing Technician

Kleinfelder, Hayward, CA
$23 - $37 per hour
3 weeks ago
Take Your Construction Career to the Next Level! Are you ready to be challenged, make a difference, and experience professional growth in your career? Kleinfelder's Construction Services team is looking for you! From construction management and observation/inspection services to laboratory testing and materials and forensic engineering, our Construction Services market helps to develop and maintain America's infrastructure and supply chain...