Medical Device Quality Assurance Specialist
Site Name: USA - California - San Francisco Posted Date: Jun 9 2021 Galvani Bioelectronics Adheres to Galvani's Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. Responsible for Inventory Control and administrator of electronic inventory management system; perform incoming inspections, First Article Inspections, and support investigation and disposition of nonconforming materials. Responsible for shipping and receiving activities; prepares shipments and execute stock transfers from SSF to or from other Galvani sites, suppliers, test facilities, and customers. Support supplier qualifications, action plans, audits, and performance monitoring for applicable suppliers Provide inputs to metrics to trend and report critical supply chain quality issues. Provide frequent communications with QA team and others as required. Support supplier corrective action requests (SCARs), Nonconforming Reports (NCMRs), and Document Change Requests (DCRs), and assist with timely closure. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Science/Supply 3+ years of relevant supplier quality experience within the pharmaceutical or medical device industries. 3+ years of experience with methods of inspection, inventory management, process control and improvement techniques Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree in science related field. A proven track record of successful Regulatory inspections/audits. Experience as an auditor/assessor. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigors, and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. *GSKLink If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.