Quality Engineering Lead - Medical Devices

Bausch Health Companies Inc.; Bothell (WA); On-site; USD 115,000 - 158,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with matching company contrib.

Discretionary time off

Paid sick time

Stock purchase plan

Tuition reimbursement

Parental leave

Short-term and long-term disability

Life insurance

AD&D insurance

Paid holidays

Employee referral bonuses

Employee discounts

Job summary

Bausch Health Companies Inc. in Bothell, WA, seeks a senior Quality Engineering leader responsible for managing the Quality Engineering team at Solta Medical and aligning QA systems with FDA/ISO regulations.

Reporting to the Director of Quality Operations, you will develop goals, procedures, and policies, drive CAPA and risk management, and mentor staff to deliver high-quality results while supporting audits and continuous improvement.

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 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 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.

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 issued resolved efficiently and economically

Skills

Bachelor's degree

Regulatory knowledge

Quality management

CAPA

Supplier management

Risk management

Leadership

Project management

Education

Bachelor's degree in sciences or technical area

Job description

Bausch Health Companies Inc. in Bothell, WA, seeks a senior Quality Engineering leader responsible for managing the Quality Engineering team at Solta Medical and aligning QA systems with FDA/ISO regulations.

Reporting to the Director of Quality Operations, you will develop goals, procedures, and policies, drive CAPA and risk management, and mentor staff to deliver high-quality results while supporting audits and continuous improvement.