Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

• 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

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.

• A minimum of 5 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.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $100K to $123K per year. 

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.