Senior Manager, Quality Engineering

The Senior Manager, Quality Engineering is responsible for the management of the Quality Engineering team at Solta Medical. The role involves developing goals, objectives, procedures, policies, and systems that align with FDA/ISO regulations and the company's mission and vision.

What You Will Do

Responsibilities include attracting and retaining talent, creating a culture of quality, supporting audits and inspections, driving process validation, and collaborating with other functions to resolve quality issues.

Why It Might Be a Fit

The ideal candidate will have a strong background in quality engineering, experience with government regulations, and excellent collaboration, team building, and negotiation skills.

Requirements

• Bachelors degree 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
• Extensive knowledge of 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
• 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 verbal and written communications skills
• Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations

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