Manager/Sr. Manager, Quality Assurance | GenomeWeb

Manager/Sr. Manager, Quality Assurance

Organization
Sequenom
Job Location
San Diego, CA
Salary
competitive salary, bonus, equity
Benefits
Job Description

The QA Manager will oversee the supplier management program and will be a key participant on product development and process improvement teams by leading the risk management product/process activities and software quality validation activities. The position also provides guidance on quality issues including validation planning, design controls and procedural recommendations for corporate standard operating procedures.

Responsibilities:
• Provides validation support of Vaisala temperature monitoring system and other facility systems for new equipment. Provides validation oversight of the calibration system module in MasterControl. (~40%)
• Provides software quality validation support for software applications systems. (20%)
• Oversees/monitors the supplier management program. Develops, maintains and evaluates the effectiveness and quality capability of suppliers. Conducts supplier audits. (10%)
• Oversees the management of the electronic Document Management function. Implements quality system modules such as deviations, internal audits and nonconforming materials in the electronic Document system as needed. (15%)
• Responsible for quality assurance activities for new product development including risk management activities. (10%)
• Participates as liaison to all laboratory locations regarding the Quality Management System. (5%)

Other Functions/Interactions:
Frequently interacts with subordinates, peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects / schedules.
• Internal Customers - Directly interacting, by such activities as internal audits and complaint investigations.
• External Customers - Acts as liaison with external parties on matters relating to Sequenom’s quality system.
• Manufacturing – Oversees the development of inspection control plans, and directing the quality system controls to support manufacturing operations.
• Engineering - Supports equipment design and validation efforts, and directing quality department support activities for product, component, processes and software validation/qualification.
• R&D – Collaborates on the implementation of Design Controls procedure. Ensures quality control resources and support for product development and product improvement projects.
• Materials – Oversees supplier quality management audit program.

Requirements

• BS/BA degree in life science or related field or equivalent combination of education and work experience. Graduate degree desirable.
• Minimum of 7 years’ experience of progressive responsibility and experience in Quality Assurance in a medical device manufacturing environment.
• Minimum 3 years previous management / supervisor experience
• Prior experience in managing and developing staff, projects and quality systems.
• In-depth knowledge of Quality System requirements and a pragmatic approach in developing, implementation and administrating a quality system within defined regulations while meeting corporate objectives.
• Must be technically knowledgeable with respect to quality systems, costs of quality, regulatory standards, supplier/subcontractor management, risk management activities, quality software validation activities.
• Must possess a high sense of urgency, initiative and common sense. Must present a professional demeanor and demonstrate an ability to work with a diverse group of individuals.
• Must be energetic, work quickly and efficiently with detail and accuracy. Must be able to effectively manage multiple priorities in a fast paced and dynamic environment.
• Must have excellent verbal and written communication skills. Requires effective communication, persuasion and technical skills to develop, present and implement ideas to corporate management.
• Ability to travel up to 10%

Sequenom is an EOE - Minority/Female/Disability/Vets

To apply, please visit http://www.sequenom.com/Careers/Jobs

How to Apply
About Our Organization

As a life sciences company, Sequenom (NASDAQ: SQNM) has a guiding vision: To improve healthcare by providing revolutionary genomic and genetic analysis solutions for the clinical research and molecular diagnostic markets.

What makes this vision a reality? Our deep commitment to "Quality of Science." For us, only the highest quality is acceptable. Sequenom team members thrive in a "science first" environment where ideas and innovation are part of daily life. This is your opportunity to work on cutting-edge science that is revolutionizing patient care.

Our innovation-driven culture means life at Sequenom is fast-paced, dynamic, and fun with rewarding benefits and performance rewards. With a clear vision for the future, all employees have the opportunity to make a difference and are encouraged to share new ideas. We foster a collaborative work environment and encourage curiosity at all levels. Our corporate headquarters is located in the heart of San Diego’s life sciences community, less than a mile from the beach.

The QA Manager will oversee the supplier management program and will be a key participant on product development and process improvement teams by leading the risk management product/process activities and software quality validation activities. The position also provides guidance on quality issues including validation planning, design controls and procedural recommendations for corporate standard operating procedures.

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