Quality Engineer – Oral Care Business Unit [Ranir]
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
We are looking for a Quality Engineer based at Ranir, a Perrigo company in Grand Rapids, Michigan.
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.
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, ensure 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.
- 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.
- 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.
- 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
- BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science
- Three years of experience in the medical device or pharmaceutical industry
- Working knowledge of applicable regulations and standards for medical device industry
- Basic experience in other quality-related areas – e.g. basic metrology, laboratory controls, internal / external audits, reliability engineering
- Working knowledge of Lean Principles, 5S, Six Sigma
- Ability to identify and use statistically-valid sampling plans
- Demonstrated ability to work with and manage internal resources, outside contractors, and suppliers
- Basic project management skills, including the ability to track action items, owners, and due dates and communicate clearly to personnel and management
- 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
- Strong verbal and written communication skills in English, with demonstrated ability to successfully work with peer group and frontline organization
- Proficiency with PC skills such as Word, Excel, PowerPoint, and Minitab software with the ability to quickly learn various in-house software applications
- Able to work independently to deliver on multiple objectives and goals according to business commitments
- Available to travel as needed to visit other company or partner locations
- Eligible to work in the United States without corporate sponsorship now and within the future
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.