Bausch Health Quality Engineer II (WA) in Bothell, Washington
Quality Engineer II (WA) (3521)
Career Opportunities: Quality Engineer II (WA) (3521)
Requisition ID 3521 - Posted 02/22/2021 - US - Bothell - Quality - US - Bothell, WA
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Quality Engineer II
Support daily production activities and review change orders for adequacy Maintain current knowledge of federal, state, and international regulations regarding GMP, ISO, MDD, and quality assurance Work with manufacturing engineering to plan, execute, and document process validations
Participate in supplier assessment, corrective action, and audits
Act as the quality representative for inspection and Material Review Board (MRB) activities
Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc.
Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis
Contribute to formalizing and instituting the quality system, writing procedures, and utilizing quality tools and techniques to ensure product compliance to CE marking and QSR requirements Complete tasks/projects in an aggressive, sense of urgency manner consistent with corporate objectives
Participate in the SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications
Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities. Other Responsibilities and Duties: • Participate in supplier quality audits • Participate in internal audits • Participate in Regulatory Assurance activities as required • Participate in audits including internal, USFDA and Notified Body
• This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience.
• Minimum 3 years in a medical device industry.
• Knowledge and experience in medical device development and manufacturing, from concept to release and distribution.
• Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601.
• Proactive, team player, enthusiastic, with high work ethics
• PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
• High level of attention to details and capable of efficient use of time
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
This position may be available in the following location(s): US - Bothell, WA
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch Health is an EEO/AA employer M/F/D/V.
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