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

Quality Engineer III (Aesthetics Med Device) (Bothell WA) Job Location: Bothell, Washington, USA Job Requisition ID: 14335 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. 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 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. 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 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. Perform principle responsibilities and duties independently with minimal mentorship and oversight required. Language and Verbal 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. Math Skills 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 apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to use MS Excel to perform calculations and interpret project results/data. Analytical and Reading Skills Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts. Physical Requirements May be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Work Environment Most work will be performed in an office and light-manufacturing environment. The noise level in the work environment is usually low to moderate. Safety 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. Benefits The range of starting base pay for this role is $89K-123K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan. Benefits package includes a 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. Equal Opportunity Employer We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. #J-18808-Ljbffr Solta Medical