Director of Quality & Regulatory Compliance
Company: ExecuNet
Location: Fremont
Posted on: January 13, 2021
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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
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