Director of Quality & Regulatory Compliance

Company: ExecuNet
Location: Fremont
Posted on: January 13, 2021

Job Description:

As the--Director, Quality you will provide strategic quality oversight for all product compliance aspects enabling the release of materials and products adhering to global regulatory applications, health authority requirements and supplemental local requirements. You will manage and set direction for the CDD Fremont organization at Company Fremont, Ca site. You will be responsible for improving the overall capability of the QA, QC functions by implementing product compliance processes according to standards and regulations (ISO13485, MDSAP, CFR 820, GMP). You will monitor progress and support of various continuous improvement activities and be accountable for all Compliance-related issues. This is a highly visible role integrated in Quality-related activities across CDD Fremont organization. As a member of the Fremont Management Team, you will report to the CDD Vice President, Quality Assurance & Regulatory Affairs with a dotted line to the CDD Fremont General Manager. Position Summary:* This candidate will lead and provide strategic direction to the Fremont, CA site for the Quality Management System (QMS) and ensure full compliance of quality, customer, and regulatory requirements the site.* The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements.* This customer facing role will require excellent interpersonal and communication skills in addition to attention to detail and a strong sense of urgency.* The candidate will be responsible for leading and managing the Quality Team* Be responsible for the maintenance and continuous improvement to the Quality Management System according to applicable standards and regulations* Act as Management Representative for the Organization* Act as the Official Correspondent relative to QMS Compliance (US FDA)* Act as QMS Site Representative* Act as QMS Leader for all Regulatory and Customer audits/inspections* Act as contact person for QMS Compliance issuesKey Responsibilities:* Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement by role modeling the values.* Establishes annual site Quality goals and objectives as part of annual Quality Improvement Plan* Manages the preparation of financial, organizational, and facility plans for the QA/RA departments.* Interfaces with applicable regulatory agencies and corporate divisions/departments, maintaining up-to-date knowledge providing business unit guidance and awareness of regulatory and quality policies and procedures. Provides regulatory and compliance expertise and interpretation to personnel or in situations requiring such expertise.* Serves as CDR site Management Representative. Hosts agency, ISO and customer audits, conducts management review and maintains overall accountability for site quality and compliance.* Serves as CDR site Management Representative. Hosts agency, ISO and customer audits, conducts management review and maintains overall accountability for site quality and compliance.* Development and implementation of quality management system procedures supporting--21 CFR 820/ISO13485/MDSAP/CE--and ISO 14001 compliance, etc.* Responsible for overall site product quality, compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements. Manages multiple functional work teams such as complaint handling, supplier management, documentation, audit, etc.* Contribute to establishment and delivery of site quality metrics, financial performance metrics and customer scorecard and satisfaction metrics.* Lead activities to improve quality management system and effectivity, product quality, site efficiency and conformance to requirements. Work closely with regulatory affairs to understand changes in requirements and respond to maintain site compliance.* Develop technical, supervisory and managerial staff to improve personal and site performance. Create developmental plans for high potential staff.* Work closely with operations to establish and promote good manufacturing practices and improve quality culture.* Interact effectively with customers to meet customer needs, provided necessary information and resolve product and process quality system problems.* Lead and participate in cross functional teams in new product development, technology transfer, process improvement and general operations.* Facilitate and participate in regular product and process quality reviews including customer reviews and site Management Review.* Establish, organize & monitor the annual Quality Plan improvement efforts.* Manage all inspections and audits by governmental agencies, notified bodies, customers and corporate functions. This includes managing inspection and audit responses and outcomes.* Lead and participate in divisional, group and corporate teams and projects.* Member of the Niche Diagnostics Management TeamMinimum Requirements/Qualifications: Position requires a 4-year degree in a technical/science area. More than 10 years in an FDA regulated industry with 5 or more years in a management position is also required. Significant experience with quality systems in an IVD/Medical device environment is also required. Incumbent must possess strong interpersonal, communication, coaching and leadership skills along with the following: * 5 -10 years of Management work experience in Quality Assurance* Written language skills (English)* PC literacy including MS Office and Outlook* Solid experience in QMS standards and requirements/regulations (ISO 9001, ISO 13485, FDA, QSR, Canada* Minimal traveling

Keywords: ExecuNet, Fremont , Director of Quality & Regulatory Compliance, Executive , Fremont, California