Senior Manager, Quality Engineering

About the role

Reporting to the Director of Quality Operations, this role is responsible for the management of the Quality Engineering team at Solta Medical and is responsible for developing goals, objectives, procedures, policies, and systems that align with FDA/ISO regulations as well as with the company mission and vision.

Responsibilities

• Attract and retain talent for the Quality Engineering, Supplier Quality, Receiving Inspection teams while also supporting their development
• Create a culture of quality that also ensures compliance with QMS, FDA QSR, ISO, MDR, and international requirements
• Support audits and inspections by regulatory agencies and notified bodies
• Drive process validation, test method development, statistical analysis, and improvement projects
• Strategically drive collaboration with CAPAs, non-conformances, and risk management activities that also focus on process improvement
• Use high level judgement regarding prioritization decisions, and tradeoffs between schedule, scope, and cost
• Partner with R&D, Maintenance, Operations, Quality Assurance and other functions to drive prompt resolution and prioritization of tasks around quality issues for product and processes while also driving the highest quality results
• Lead the oversight and influence the nonconformance system (product and non-product related) in a timely manner and serves as an activist and mentor in problem solving and root causing activities
• Proactively drive and mentor continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically

Qualifications

• Bachelor's degree required in a sciences or technical area relevant to the medical device industry
• Minimum of 7 years of medical device industry experience
• Minimum of 5 years of Management experience
• Extensive knowledge and experience with government regulations to assure development of Quality Systems conforming to relevant regulations
• Extensive knowledge of the requirements for international quality systems, including ISO-9001/EN 46001, ISO 13485, MDR, Vigilance Systems, Notified Bodies, CE marking and IEC 60601
• Demonstrated collaboration, team building, negotiation & conflict resolution skills
• Knowledge of and working experience with Corrective Action / Preventive Action (CAPA)
• Knowledge of and working experience with Supplier Management (Supplier selection / assessments / monitoring / audits / metrics)
• Demonstrated knowledge of and working experience with Risk Management (ISO 14971, FMEAs, FMECAs, Hazard Analysis)
• Multi-tasks, prioritizes and meets deadlines in timely manner
• Strong organizational, planning, and follow-up skills and ability to hold others accountable

Skills

• Language & Verbal Skills: Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization; ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status; ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations; ability to write reports, specifications, business correspondence, and procedure manuals
• Analytical & Reading Skills: Exceptional analytical, problem solving & root-cause analysis skills; ability to multitask, define problems, collect data, establish facts, and draw valid conclusions; demonstrated ability interpreting a 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

Pay

The range of starting base pay for this role is 115K – 158K. 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

• Comprehensive Medical (includes Prescription Drug)
• Dental
• Vision
• Flexible Spending Accounts
• 401(k) with matching company contribution
• Discretionary time off
• Paid sick time
• Stock purchase plan
• Tuition reimbursement
• Parental leave
• Short-term and long-term disability
• Life insurance
• Accidental death & dismemberment insurance
• Paid holidays
• Employee referral bonuses
• Employee discounts

Work Environment

• Physical Requirements: May be required to perform lifting tasks of up to 30 pounds for short durations; duties may involve standing and/or walking for extended periods of time; daily keyboard data entry; specific vision abilities required include close vision; limited travel (0-10%)
• Work Environment: Most work will be performed in an office environment; noise level is usually low to moderate