Senior Quality Engineer

$130,000 - $145,000/Yr

Ferring Pharmaceuticals - Roseville, MN

Full-time - Mid Level

Roseville, MN

Merchant Wholesalers, Nondurable Goods

About the position

The Sr. Quality Engineer at Ferring is responsible for providing quality assurance support in compliance with regulatory requirements related to biologic therapeutics and cGMP. This role focuses on supplier management, internal and external audits, and ensuring product quality through effective investigations and process improvements. The position requires collaboration with various departments and regulatory bodies, and it emphasizes a commitment to continuous improvement and customer service.

Responsibilities

• Primary focus on supplier management including supplier qualification, audits, SCARs, and authoring Quality/Technical Agreements.
• Perform and support internal and external audits.
• Interface and collaborate with internal departments and external regulatory bodies regarding compliance needs.
• Review and approve Complaint, CAPA, Audit Findings, and Deviation investigations to ensure effective investigations are completed.
• Provide continued quality system support by improving processes and systems and updating site procedures.
• Participate in third party audits as required.
• Document Quality Issues resolutions within CAPA, SCAR, Deviation, and Audit findings to ensure robust actions are taken to eliminate re-occurrence.
• Guide, coach, and train personnel on auditing, Root Cause Analysis, CAPA, and deviations.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics comply with internal requirements and goals.
• Conform with all regulations, policies, work procedures, and safety rules.
• Manage or support implementation of electronic QMS.
• Contribute to continuous process improvement efforts and eliminate waste.
• Provide a customer service attitude when interacting with internal and external customers.

Requirements

• Bachelor's degree in science or engineering discipline.
• Minimum 6 years' experience, including 4 years in supplier quality and 3 years in FDA regulated medical device or pharmaceutical industry.
• Demonstrated experience in problem solving and root cause analysis methods.
• Demonstrated experience in process risk management methods.
• High proficiency in standard electronic business tools: Outlook, Word, PowerPoint, Excel, and ERP/MRP systems.
• Effective communication skills of technical issues to various functional levels.
• Ability to make data-driven decisions and a passion for change and continuous improvement.

Nice-to-haves

• Certified auditor preferred.

Benefits

• Comprehensive healthcare (medical, dental, and vision) with a premium differential.
• 401k plan with company match.
• Short and long-term disability coverage.
• Basic life insurance.
• Wellness benefits.
• Tuition reimbursement for certain expenses.
• 40 hours of sick time.
• Vacation time accruing up to 150 hours in the first four years and 187.50 hours in the fifth year.
• 12 to 13 paid holidays per year.
• 26 weeks of paid parental leave.