Quality Engineer 3

• Onsite 4 days - 5th day remote

• 21 CFR 820 / QMSR
• Basic statistical analysis skills for interpreting test data.
• Design Transfer
• Experience in Design Control principles
• Experience in Medical Device domain or related regulated industry
• ISO 14971 Risk Management
• Risk Management activities

• Disposable medical device experience

• Project: The projects currently in progress are a material change of an existing component, and revision of IFU's  across a wide spectrum of products.
• However, the project load in general is dynamic and changes over time, being primarily sustaining related design control product changes (i.e. vendor driven changes mostly).

• This position is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices.
• This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

• Consistent application of technical principles, theories, concepts, techniques and quality sciences / tools (e.g. Acceptance sampling theory and application, statistical process control methods and application, measurement systems / test method knowledge and analysis, quality planning, failure analysis and investigation, design of experiments, process mapping and value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools: pareto, box plots, histograms, scatter diagrams etc., risk management, supplier quality management, auditing, design / development tools, process validation, software validation, etc.).
• Is a team member representing Quality on sustaining engineering projects.
• Writes, reviews, and approves protocols, reports, and data analysis.
• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
• Influences and/or directs others across organization and cross functionally.

• Requires a minimum of a bachelor's degree.
• A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.
• Candidates must have experience within the medical device or equivalent regulated industry.

• Candidates with a science, technology, engineering, or math degree.

• Proven problem-solving skills.
• Working knowledge of statistical analysis and software use (Minitab preferred).
• Basic use of risk management tools.
• General application of design controls.

• Oral and written communication.
• Ability to work in cross-functional teams.
• Process validation experience (IQ/OQ/PQ).
• Design change experience including: Design Controls / Design verification / Design validation / Risk management
• Corrective and Preventive action.
• Project management.
• Supervisory experience

Pavan.p@sunrisesys.com