Quality Engineer/Complaints

$65,000 - $90,000/Yr

Bausch Health Companies - B, WA

Full-time - Entry Level

B, WA

5,001-10,000 employees

Chemical Manufacturing

About the position

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence. We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact. Reporting to the Materiovigilance Manager, as the Quality Engineer specializing in Materiovigilance and Complaints, you will lead the charge in investigating product complaints and adverse events. You'll collaborate with cross-functional teams to deliver thorough investigation reports that comply with Solta procedures, FDA regulations, ISO standards, and other essential quality system requirements and regulatory guidelines.

Responsibilities

• Investigate Product Complaints: Independently investigate product-related complaints and adverse events using designated databases, ensuring compliance with company procedures.
• Risk Assessment: Assess reported issues to ensure they are addressed in risk documentation and/or product labeling.
• Root Cause Analysis: Evaluate issues against product and device history to identify root causes and trends.
• Cross-Functional Collaboration: Participate in cross-functional teams to investigate potentially reportable events or those with potential business impact.
• Timely Reporting: Manage timelines for complaint investigations to ensure timely reporting and resolution.
• Corrective Actions: Identify applicable corrective and preventative actions to facilitate complaint closure.
• Customer Interface: Interface with internal and external customers and international affiliates.
• Quality Processes: Develop or contribute to the development of quality processes for complaint handling.
• Data Analysis: Compile complaint data and prepare and present complaint metrics and trend reports in support of Quality Review Board and Management Review.
• Field Failure Correlation: Work with Service and Support team to correlate complaint data with field failure data.
• Regulatory Reporting: Generate periodic reports as requested by government agencies and/or Notified Bodies.
• Technical Input: Provide technical input for adverse event investigations.
• Other duties as assigned.

Requirements

• Educational Background: Bachelor's degree in Science or Engineering or equivalent experience.
• Experience: Minimum of 2 years of progressive quality assurance background in medical device manufacturing with hands-on experience in complaint processing.
• Technical Writing: Proficient in technical writing in English.
• Regulatory Knowledge: Working knowledge of FDA QSR, ISO 13485:2003, and applicable global regulatory requirements for complaint handling.
• Risk Management: Working knowledge in risk management for medical devices.
• Data Analysis: Excellent skills in tracking, trending, analyzing, and reporting key quality metrics for complaint history using electronic database systems.
• Software Proficiency: Extensive knowledge and experience in utilizing standard software systems, including Microsoft Office.

Nice-to-haves

• Technical Skills: Proficient in SQL, Python, PowerBI, and Excel macros.
• Analytical Abilities: Possess strong analytical skills with a thorough understanding of programming and database environments.

Benefits

• Comprehensive Medical (includes Prescription Drug)
• Dental
• Vision
• Health Savings Account with company contribution
• Flexible Spending Accounts
• 401(k) matching
• Discretionary time off
• Paid sick time
• Tuition reimbursement
• Parental leave
• Short-term disability
• Long-term disability
• Life insurance
• Accidental death & dismemberment insurance
• Paid holidays
• Employee Assistance Plan
• Commuter benefit
• Recognition awards
• Voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping)
• Employee referral bonuses
• Employee discounts