Sr. Quality Assurance Engineer

Primary focus of this role will be to provide Quality Engineering support in the execution of design control and risk management deliverables associated with new and existing products to meet global medical device regulations.

The role also provides Quality Engineering support for manufacturing and supplier related activities associated with new and existing products.

• Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and Quality System requirements.
• Generate and ensure compliant completion of Quality deliverables such as Design Reviews, Engineering Change Orders, Design & Development Plan, Risk Management, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, Packaging, Labeling, Statistical sampling plans, etc.
• Provide Quality Engineering support in as part of supplier qualification, audit, ongoing monitoring, and supplier improvement activities.
• Develop and deploy Quality System related processes, tools, training, and metrics to enabling us to meet business needs and comply and global medical device regulations.
• Serve as Subject Matter Expert on Design Controls and Risk Management medical device regulatory requirements.
• Lead CAPA, post market surveillance and other quality improvement efforts.
• Provide key quality trending information and data for use in periodic reviews.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).

• BS in STEM (Science, Technology, Engineering, Mathematics).
• 5+ years Quality Engineering design controls/risk management experience within Medical Device industry for companies with greater than $1bn USD annual revenue.
• Demonstrated competency with the 21 CFR, 820, Medical Device Directive, EN ISO 13485, and EN ISO 14971, particularly with respect to product design & development and product risk management.
• Familiarity with the EU MDR regulation and Post Market Surveillance requirements.
• Strong communication and presentation skills.
• Competent in Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
• Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross functional environment.