Senior Manager, Quality Engineering

Scorpion Therapeutics; Bothell (WA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical benefits (including prescribed

Dental and Vision

401(k) match

Tuition reimbursement

Paid holidays

Parental leave

Job summary

Scorpion Therapeutics is seeking an experienced Quality leader to oversee Quality Engineering, Supplier Quality, and Receiving Inspection, ensuring adherence to QMS, FDA QSR, ISO, and MDR requirements.

You will drive audits, process validation, and risk-based improvements while mentoring teams to prevent issues and resolve root causes across R&D, Maintenance, Operations, and Quality Assurance.

Qualifications

• Bachelor’s degree in sciences/technical area relevant to medical devices.
• 7+ years medical device industry experience; 5+ years management experience.
• Extensive knowledge of government regulations for Quality Systems.
• Knowledge of ISO 9001/EN 46001, ISO 13485, MDR, vigilance systems, CE marking, IEC 60601.
• Strong collaboration, team building, negotiation/conflict resolution.
• Working knowledge of CAPA; Supplier Management; Risk Management (ISO 14971, FMEAs/FMECA, hazard analysis).
• Strong organizational/planning skills; ability to meet deadlines.

Responsibilities

• Attract and retain talent for Quality Engineering, Supplier Quality, and Receiving Inspection; support development.
• Create a culture of quality ensuring compliance with QMS, FDA QSR, ISO, MDR, and international requirements.
• Support regulatory agency and notified body audits/inspections.
• Drive process validation, test method development, statistical analysis, and improvement projects.
• Collaborate with CAPAs, non-conformances, and risk management to focus on process improvement.
• Use judgment for prioritization and tradeoffs between schedule, scope, and cost.
• Partner with R&D, Maintenance, Operations, Quality Assurance, and others to resolve quality issues and drive high-quality outcomes.
• Lead oversight of the nonconformance system (product and non-product) and mentor problem-solving/root-cause activities.
• Mentor and drive continuous improvement to prevent issues and resolve them efficiently.

Skills

Regulatory knowledge

CAPA & Root Cause

Quality leadership

Risk Management (ISO 14971)

Cross-functional collaboration

Project planning

Education

Bachelor's degree in sciences/technical area

Job description

Responsibilities:

• Attract and retain talent for Quality Engineering, Supplier Quality, and Receiving Inspection; support development.
• Create a culture of quality ensuring compliance with QMS, FDA QSR, ISO, MDR, and international requirements.
• Support regulatory agency and notified body audits/inspections.
• Drive process validation, test method development, statistical analysis, and improvement projects.
• Collaborate with CAPAs, non-conformances, and risk management to focus on process improvement.
• Use judgment for prioritization and tradeoffs between schedule, scope, and cost.
• Partner with R&D, Maintenance, Operations, Quality Assurance, and others to resolve quality issues and drive high-quality outcomes.
• Lead oversight of the nonconformance system (product and non-product) and mentor problem-solving/root-cause activities.
• Mentor and drive continuous improvement to prevent issues and resolve them efficiently.

Qualifications:

• Bachelor’s degree in a sciences/technical area relevant to medical devices.
• 7+ years medical device industry experience; 5+ years management experience.
• Extensive knowledge of government regulations for Quality Systems.
• Knowledge of international quality systems: ISO 9001/EN 46001, ISO 13485, MDR, vigilance systems, notified bodies, CE marking, IEC 60601.
• Strong collaboration, team building, negotiation/conflict resolution.
• Working knowledge of CAPA; Supplier Management; Risk Management (ISO 14971, FMEAs/FMECA, hazard analysis).
• Strong organizational/planning skills; ability to meet deadlines.

Benefits:

• Medical (includes prescription), Dental, Vision, Flexible Spending Accounts, 401(k) match, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- & long-term disability, life and accidental death/dismemberment insurance, paid holidays, referral bonuses, employee discounts.