Principal Quality Engineer

The Principal Engineer, Quality will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes.

JOB SUMMARY:

Develop a local strategy that is aligned with the business strategy and implements related tactical activities. Translates strategic needs of the division into executable long-range programs and projects. Provide solutions to a wide range of difficult problems. Solutions are compliant, Innovative, thorough, practical, and consistent with organizational objectives. Leads projects with a cross-functional broader scope.

• Represents team on cross-functional projects with other functional leaders.
• Directly influences project direction and scope.
• Interacts effectively with employees, managers, and cross-functional peers.
• Excels in effective and positive communications.
• Contributes functional skills and expertise broadly.
• Scope includes one or more QA functions with general knowledge of other related disciplines.
• Provides guidance and trains, other Professionals and Technicians.
• May provide oversight to one or more QA professionals and/or contractors.
• Quality System Compliance – Demonstrates a complete understanding of the standards and regulatory bodies that regulate our industry.
• Ensures compliance with Division and Corporate policies and procedures.
• Implements and maintains the effectiveness of AVD’s Quality System, including the subsystems and key processes that govern the area by identifying compliance risks.
• Risk Management – Defines the business results expected from risk management strategies and projects.
• Leads AVD in determining the changes, improvements, and investments needed to support the Risk Management process in the Quality System and business-driven objectives.
• Makes independent decisions within broad parameters while assuring that these decisions are compliant with site-level policies and procedures and are aligned with the appropriate quality system.
• Reviews and approves Risk management documentation.
• Complaint Evaluation – Investigates complex complaints and carries out tasks with management guidance.
• Provides overall direction.
• Ensures compliant documentation in cross-functional areas of support.
• Design Control / Documentation & Change Control – Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy.
• Acts as Process Owner and represents the site as an SME or Process Community Member.
• Negotiates complex changes.
• Identifies key processes that may be impacted as a result of the change.
• Effectively reviews and discusses changes with key stakeholders.
• Quality Engineering – Draws conclusions reflecting broad business and quality needs.
• Champions new initiatives and acts as the catalyst for change within and potentially across divisions.
• Negotiates complex quality decisions.
• Participates as SME in audits.
• Acts as a consultant at site and Division or in partnership with suppliers for developing quality-related strategies for major projects.

EDUCATION AND EXPERIENCE:

REQUIRED:

• Bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience. 
• 10 years of experience in Quality or a related field with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• Demonstrated and impactful strong project management skills required.
• Experience in the health care industry.
• Has a history of completing successful cross-functional projects and driving positive compliance outcomes
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. 
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational, planning, and follow-up skills
• Ability to travel internationally to support international manufacturing sites. Ability to travel approximately 15-25%.

PREFERRED:

• ASQ Certified Quality Engineer preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.