Quality Engineer III (Bothell, WA)

Bausch Health Companies • Bothell, WA

78d • $89,000 - $123,000

About The Position

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. 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. Please note, this position is on site in Bothell, WA.

Requirements

• Minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience
• A minimum of 5 years of Quality Engineering experience in a regulated industry
• Strong drive to troubleshoot/problem solve and identify root cause
• Strong collaboration and development skills
• Proactive, team player, enthusiastic, with high work ethics
• PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
• High level of attention to details, capable of efficient use of time and project management skills essential
• Ability to perform principal responsibilities and duties independently with minimal mentorship and oversight required

Responsibilities

• Quality point of contact supporting daily production activities and review change orders for adequacy
• Participate in supplier assessment, corrective action, and audits
• Act as the quality representative for inspection and Material Review Board (MRB) activities
• Act as a quality representative on manufacturing line down issues to effectively drive containment and root cause analysis
• Work with manufacturing engineering to plan, execute, and document process validations
• Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc.
• Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis
• Contribute to formalizing and instituting the quality system, writing procedures, and utilizing quality tools and techniques to ensure product compliance to CE marking and QSR requirements
• Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives
• Manage sterilization procedures and maintenance activities and the environmental monitoring program
• Participate in the SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications
• Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities.
• Able to analyze data and present findings in a logical manner.
• Participate in supplier quality audits
• Participate in internal audits
• Participate in Regulatory Assurance activities as required
• Participate in audits including internal, USFDA and Notified Body

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees