Quality Engineer III (Aesthetics Med Device) (Bothell WA)

Responsibilities

• Quality point of contact supporting daily production activities and review change orders for adequacy
• Participate in supplier assessment, corrective action, and audits
• Act as the quality representative for inspection and Material Review Board (MRB) activities
• Act as a quality representative on manufacturing line down issues to effectively drive containment and root cause analysis
• Work with manufacturing engineering to plan, execute, and document process validations
• Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc.
• 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
• Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives
• Manage sterilization procedures and maintenance activities and the environmental monitoring program
• 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
• Able to analyze data and present findings in a logical manner
• 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

Qualifications

• This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience
• A minimum of five years of Quality Engineering experience in a regulated industry
• Strong drive to troubleshoot/problem solve and identify root cause
• Strong collaboration and development skills
• 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, capable of efficient use of time and project management skills essential

Skills

• Ability to read, analyze, and interpret engineering drawings and specifications, general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, specifications, business correspondence, and procedure manuals in English
• Ability to effectively present information and respond to questions from groups of managers, clients, and customers
• Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status
• Ability to work with mathematical concepts such as probability and statistical inference, process capabilities and fundamentals of plane and solid geometry and trigonometry
• Ability to use MS Excel to perform calculations and interpret project results/data
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to read technical and clinical literature and documents and extract important concepts

Benefits

• Comprehensive Medical (includes Prescription Drug), Dental, Vision,
• Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts