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QA Lifecycle Management Engineer (TEMPORARY)

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives. 

Duties


Job Overview:



The Global Quality Lifecycle Engineer’s primary function will be responsible for combination products (device) post market activities that include; risk management, product complaints, adverse events, quarterly system management review, annual product review and assessment of impacts from the evolving regulatory landscape to product line documentation. Secondary functions would be to support premarket design and development programs.


This position requires a broad range of knowledge and experience with the design and development of combination products and the regulatory requirements governing human use and commercialization.


Responsibilities:



Organize, analyze and report on quality metrics for market product that contain device components and assemblies.


Perform the required post market risk management activity to maintain the risk profile and associated controls for all device products.


Perform periodic assessment of regulatory requirements against marketed products and associated controlled documents.


Facilitate revisions to SOPs as required to support the current state of business.


Support the premarket activities in the design and development of combination products.


Requirements:



Experience working in a Quality Management Systems, specifically CFR Title 21 Part 820 and ISO 13485.


Proficient with GxP practices in the Pharma and Medical Device Industries.


Experience in working with Electronic Change Control Systems (EDMS).


Experience in technical writing with SOPs, Work Instructions, Technical Reports, FMEA’s.


Experience with updating risk assessments based on product complaint data processing.



Skills




Proficient with computer systems using the following software; MS Word, MS Excel, MS Outlook, VISIO


Effective communicator using verbal, written and graphical techniques


Effective working in a cross functional group and taking notes in meetings


Min 7 year of experience working in Pharma or Medical Device industries in a quality department role.

Education


BS in engineering or sciences, or equivalent combination of education and experience would be considered.

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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