Job 08-011
Quality Assurance Manager
Summary & Scope of Position:
Manage and implement Quality Assurance programs for compliance with national and international regulations and standards.
Primary Responsibilities:
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Oversee assigned quality assurance activities related to FDA regulations and ISO standards for medical devices (CAPA, internal audit, risk assessment)
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As necessary, supervise and provide guidance to Quality Assurance personnel
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Create and implement systems for ensuring the effectiveness of the Cerus quality management system
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Identify, organize and adapt implementation of new state/local/federal/international regulations and standards
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Write/revise/ review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
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Perform internal and supplier quality audits and facilitate corrective actions
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Interact with suppliers on quality matters
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Host/support inspections of facilities and contract organizations by national and international regulatory agencies and notified bodies
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Regularly interact with Cerus management regarding quality matters
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Assure completion of departmental tasks and projects to meet the needs of internal and external customers
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Ensure budgets, schedules, staffing, performance and safety requirements are met
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Perform other related duties as required (will include projects in the areas of compliance and quality systems
Qualifications/Requirements/Skills:
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Bachelor’s degree in a scientific discipline or equivalent with a minimum of 5 years experience in pharmaceutical, medical device and/or biotechnology companies
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Minimum of 5 years experience in quality assurance
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Experience in a supervisory capacity or managing projects
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Broad based regulation/standards background and current understanding of quality assurance trends and intents
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Training and mentoring skills; strong leadership skills
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Strong communication (verbal, written, listening) and interpersonal skills with ability to communicate across multiple disciplines
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Proficient in writing SOPs, reports and quality documentation
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Experience reviewing technical documentation and reports
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Proficient in Microsoft Word, Visio and Excel
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Time Management (timelines, schedules, task prioritization).
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Attention to detail and accuracy
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Flexible; ability to adapt to changing priorities
How to Apply
Interested Candidates may submit a resume by one of the following methods.
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By Mail:Cerus Corporation
Attn: Human Resources
2411 Stanwell Dr.
Concord, CA 94520
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By Fax:
925-288-6090 |
Online:hr@cerus.com |
For Staffing Vendors
Cerus does not accept unsolicited resumes from staffing vendors, including recruitment agencies and/or search firms, nor does Cerus pay fees to any such vendors without a current agreement on file. Please do not contact or solicit Cerus hiring managers regarding these matters.
Equal Opportunity Employer
Cerus Corporation is proud to be an equal opportunity employer and extends employment to men and women from culturally diverse backgrounds. We respect and value individual differences and recognize each employee as an integral member of our company. Our work force reflects these values and celebrates the individuals who make up our growing team.
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