Sr. Quality Engineer - Capital Equipment

Proclinical is looking to hire a Senior Quality Engineer of Capital Equipment for a leading biotechnology company located in San Francisco, CA.

Job Responsibilities:

• Support company Capital Equipment operation
• Review and modify product designs and process documentation for quality characteristics
• Participate in the establishment and maintenance of the PFMEA for Capital Equipment
• Identify and support process improvement projects to improve product reliability and manufacturing capacity increases.
• Support complaint handling program, including complaint analysis, investigation, and follow up
• Support corrective and preventive action (CAPA) program.
• Support training program to communicate Quality System requirements to organization at all levels.
• including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements
• Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life,
• reliability, and electrical safety
• Review and provides feedback of protocols and reports, test vendor qualification, and testing management

Skills and Requirements:

• Bachelor's degree preferably in an engineering or scientific discipline from four-year college or university.
• Preferably Electrical or Mechanical Engineer degree
• 5-7 years related experience and/or training; or equivalent combination of education and experience
• Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military, nuclear
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Must have a working knowledge of statistics
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,
• ISO 11135, and the EU Medical Device Directive is a plus
• Demonstrate the ability to implement ISO 14971, including risk evaluation techniques

If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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