• 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
• Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings
• Work with manufacturing engineering to plan, execute, and document process validations
• Identify and communicate product safety requirements to design team
• 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
• Experience with generating technical files is preferred
• 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.
Other Responsibilities and Duties:
• Lead in supplier quality audits
• Lead internal audits
• Participate in Regulatory Assurance activities as required
• Participate in audits including internal, USFDA and Notified Body
Experience, Education, Training, Skills, Traits:
• This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience.
• Minimum 5 years in a medical device industry.
• Extensive knowledge and experience in medical device development and manufacturing, from concept to release and distribution.
• Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601.
• 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
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.
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.
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.
Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.
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.