Principal Supplier Quality Engineer

📋 Description

• Oversee the lifecycle of supplier change notifications, which includes evaluation, risk assessment, approval, tracking, and resolution.

• Conduct trend analyses of supplier quality data to proactively identify potential risks.

• Examine, analyze, and report on supplier trends, focusing on the effectiveness and sustainability of corrective measures.

• Collaborate with stakeholders such as Supply Chain, Incoming Quality, Quality Assurance, Technical Services, and Manufacturing to address supplier quality challenges.

• Identify, document, and rectify discrepancies between Supplier Quality practices and corporate as well as local procedures, ensuring compliance with regulations and procedures.

• Provide guidance and mentorship to colleagues on the application of statistically based quality engineering techniques, including data analysis, result interpretation, and risk-based decision-making.

• Evaluate current supplier quality processes and propose enhancements to boost compliance, efficiency, and robustness.

• Assist in supplier qualification, performance monitoring, and ongoing quality development initiatives, which include both on-site and remote engagements.

• Engage in supplier audits, quality evaluations, and business reviews as necessary.

• Ensure that supplier quality activities adhere to cGMP standards, global pharmacopoeias, and international regulatory requirements.

• Create and maintain clear, concise, and compliant documentation, metrics, and reports for both internal and external stakeholders.

⛳️ Requirements

• A Bachelor’s degree is required, ideally in a Science or Engineering field.

• 3-4 years of experience in Quality, Manufacturing, or Engineering is required; experience in Supplier Quality is highly preferred.

• Experience in the biopharmaceutical, pharmaceutical, medical device, combination product, and/or biologics industries is strongly preferred.

• Proven experience in root cause analysis, the application of quality tools, corrective and preventive action (CAPA) methodologies, and data analysis and reporting.

• Comprehensive knowledge of pharmaceutical regulations and international standards, including FDA cGMP, Eudralex, ISO 13485, ISO 9001, and global aseptic manufacturing regulations.

• Demonstrated ability to manage quality relationships with key suppliers, including coordination and leadership of both on-site and off-site supplier quality development activities.

• Strong project management skills, capable of independently managing multiple moderate to high complexity issues with minimal supervision in a fast-paced environment.

• Business acumen with a solid understanding of current and emerging industry trends, policies, technologies, and regulatory expectations.

• Willingness and capacity to travel 30%-50%, including international travel.

• Flexibility for a hybrid work environment (remote and on-site), with regular visits to Bloomington, IN and/or Halle, Germany as needed to support Simtra operations.

🏝️ Benefits

• Medical & Dental Coverage

• Flexible Spending Accounts

• Life and AD&D Insurance

• Supplemental Life Insurance

• 401(k) Retirement Savings Plan with Company Match

• Paid Holidays

• Paid Time Off

• Paid Parental Leave and more

• Adoption Reimbursement Program

• Education Assistance Program

• Employee Assistance Program

• Community and Volunteer Service Program

• Employee Ownership Plan

• Short and Long-Term Disability Insurance

• Vision Coverage

• Accident Insurance

• Critical Illness Insurance

• Hospital Indemnity Insurance

• Identity Theft Protection

• Legal Services and more

• Workout Facility

• Cafeteria

• Credit Union