Manager of Quality Engineering Job in Hayward 94545, California US
Solta Medical, Inc. (SLTM) is a global leader in the medical aesthetics market providing innovative, safe, and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address a range of skin issues under the industry's six premier brands: Thermage®, Fraxel®, Isolaz®, CLARO®, Clear + Brilliant™ and Liposonix®. Thermage is an innovative, non-invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Isolaz was the first light based system indicated for the treatment of inflammatory acne, comedonal acne, pustular acne, and mild-to-moderate inflammatory acne. CLARO is a personal care acne system that is the first FDA cleared over-the-counter IPL device that uses a powerful combination of both heat and light to clear skin quickly and naturally. Clear + Brilliant is a unique, cost-effective treatment that utilizes safe, fractional laser technology to prevent and maintain early signs of aging. Liposonix is a non-surgical treatment to reduce waist circumference with advanced high-intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat beneath the skin. Since 2002, approximately one million Thermage, Fraxel and Isolaz procedures have been performed in over 100 countries.
Our mission is to be the leader in developing transformational aesthetic products, procedures and services; building world class brands; and providing long term value for our stakeholders.
Solta Medical is looking for dedicated individuals who thrive in a creative, challenging and professional environment - where respect for the energy of new ideas, diversity and teamwork can be found at every level of the organization. We create new opportunities for physicians and the patients they serve. And, of course, opportunities for our employees to grow and thrive.
Position Title: Manager of Quality Engineering
FLSA Status: Exempt
Reports To: VP of Quality Compliance
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessary all inclusive of the duties and responsibilities for this position title.
• Manage and oversee Quality Engineering and Software Quality functions.
• Represent Quality in Design Control activities to ensure compliance to quality systems procedures, regulations, and standards. Provide guidance for design and development planning, risk management, software lifecycle, and design verification and validation.
• Ensure compliance and electrical safety testing is performed to appropriate standards.
• Identify specifications for verification and validation and reliability testing, plan and perform validation and reliability testing.
• Generate or analyze use, design, and process Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), hazard analysis, risk/benefit analysis, and adverse event reports (websites, peer-reviewed journals, etc.).
• Develop product Design History Files (DHR), Technical Files, and Device Master Records (DMR).
• Partner with Operations, RD, Marketing and other departments to ensure products are effectively transferred to internal or contract Manufacturing. Provide quality review process validation and test method validations protocols and reports.
• Maintain current knowledge of federal state and international regulations regarding GMP ISO MDD and quality assurance issues.
• Responsible to ensure all documentation reports tests and results meet the requirements of Regulatory Filings and Technical files for CE filings.
• Develop new Quality Plans and strategies master validation plans design validation protocols and reports process validation protocols and reports and design and verification plans.
• Take a lead role in formalizing and instituting the quality system writing functional and system level specifications along with utilizing effective quality tools and techniques to meet product compliance to CE marking and QSR requirements.
• Plan schedule and complete 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.
Experience, Education, Training, Traits:
• This position requires a minimum of an undergraduate degree in engineering or science (preferably in Electrical or Mechanical Engineering).
• Minimum 5 years in a medical device industry.
• Minimum 2 years of management experience. Project management experience a plus.
• Extensive knowledge and experience protocol preparation and report writing.
• 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 ethic.
• 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.
• Experience with generating technical files and constructional data forms is preferred.
• Experience in risk analysis (e.g. establishing risk documents such as hazard analysis and FMEA).
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 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.
Solta Medical, Inc. is an equal opportunity employer.