Senior Quality Engineer - Req Medical Device Exp (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.
• Process validation, software validation.

Requirements

• 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.
• Process validation, software validation.

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.