Senior Quality Engineer - Req Exp in Medical Device (Onsite)

Job Responsibilities

• Consistent application of technical principles, theories, concepts, techniques and quality sciences / tools.
• 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.
• Risk management, supplier quality management, auditing, design / development tools, process validation, software validation.
• Handles projects and tasks, from product inception through product launch and maintenance.
• 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.

Qualifications

• 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.

Preferred Qualifications

• Candidates with a science, technology, engineering, or math degree.
• Applied knowledge of applicable quality, engineering, regulatory, Corporate and/or Unit requirements.
• 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.

Preferred Skills

• 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.