This position is responsible for identifying and mitigating regulatory, product, and business risks during new product development, process development and validation, production, and post-market surveillance activities.
Principal Quality Engineers are required to demonstrate daily systematic and logical use of risk management tools and quality engineering principles to quantify risks and take action that is commensurate with the risk, ensuring all activities are performed in compliance with quality system processes.
This position expected to fully understand quality engineering tools (e.g. specification analysis and creation, statistical testing, data distribution analysis, gauge R&R) and demonstrate appropriate use of these tools in the course of their work. Principal Quality Engineers are expected to have a working knowledge of the entire QMS and expert experience in one or more systems – e.g. CAPA, Internal Audit, Supplier Quality, Nonconforming Material, etc.
This position is the technical lead for quality engineering, responsible for bringing best-practice quality engineering tools to the organization by communicating, working with, and mentoring other quality engineers. Principal Quality Engineers should monitor technical trends in the industry and lead efforts to prepare the quality personnel and management for changes.
- Provide advanced new product development support as part of a cross-departmental project team, including risk management documentation review, specification evaluation, and compliance with quality system processes. Provide guidance on design controls and ensure conformance to the process. Assist with specification creation; aligning tolerances with risks during product development.
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test methods, statistical data analysis, statistical process control, and sample plans.
- Creation and annual updates of product risk management reports using risk management tools (D/PFMEA) and other risk management data.
- Self-identify, develop, and lead cross-functional quality improvement projects for products or systems using quality engineering tools such as Design of Experiments (DOE)
- Write process validation protocols, appropriately referencing risk management documentation, specifications, statistical sampling requirements, and acceptance criteria. Ability to navigate complex process validation requirements, recognizing opportunities for risk and appropriately challenging the process for those risks as part of the process validation strategy.
- Oversight of process validation protocol execution; writing the post-execution report and proper handling any deviations during execution. Work with R&D, Operations, and Engineering to determine the proper deviation resolution based on the risk.
- Use advanced root cause analysis to address issues during product development, production, and post-market surveillance activities, including brainstorming, 5-whys, and fishbone diagrams. Lead cross-departmental teams on root cause analysis.
- Execute nonconforming material investigations, including root cause analysis, corrective actions, and material dispositions. Recognize opportunities to expand corrective actions across similar processes and work to implement.
- Engage with other quality employees, including quality technicians, and team leaders as a mentor for quality skillset growth
- Actively participate in improving quality culture; champion the value of quality to the organization, communicating and supporting quality improvement initiatives
- Teach basic quality engineering tools to other functional areas of the organization through interactions and classes
- Execute complaint investigations, including root cause analysis and corrective actions. Thorough understanding of complaint trending and use of statistical tools to determine if action is required.
- Ensure effective change control using thorough change evaluation and use of supporting documentation
- Act as SME and support external regulatory inspections / audits
- Responsible for keeping current with, maintaining, reviewing and implementing any applicable regulations and standards
- Bachelor’s degree in engineering, Life Science, Engineering, or Physical Science
- Minimum 5 years’ experience in a Quality Engineering role, medical device or pharmaceutical industry, leading investigations, resolution of corrective actions, and root cause analysis
- Demonstrated success working with external quality and regulatory organizations (e.g. ASQ, RAPS, TOPRA) with an understanding of regulatory requirements
- Advanced experience in one or more quality-related areas – e.g. advanced metrology, laboratory controls, internal / external audits, reliability engineering
- Ability to create statistically-valid sampling plans for use
- Working knowledge of applicable regulations and standards
- Working knowledge of Lean Principles, 5S, Six Sigma
- Strong project management skills, including the ability to track action items, owners, and due dates and communicate clearly to personnel and management
- Strong proficiency with Microsoft Suite and Minitab software, with the ability to quickly learn various in-house software applications as needed
- Ability to communicate effectively (written and verbal) in English with associates and stakeholders globally; demonstrated ability to work with senior leadership, multi-national teams, and frontline organization
- Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
- Ability to use creative reasoning and logic to address novel situations and fulfill regulatory and customer requirements
- Well-organized with proven time management skills; able to deliver on multiple projects with consistent work of high-quality
- Works effectively as an individual performer or as a member of a team; provides coaching and leadership throughout
- Demonstrated ability to work with and manage internal resources, outside contractors, and suppliers