Engr 3, Quality

Job Summary

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.

Job Responsibilities

• 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.

Education and Experience

• 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.

Shift

• [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]

Start

• [Disposable medical device experience]

Benefits

• Free Healthcare Insurance
• Vision and Dental Insurance
• 401(k) Retirement Plan
• Free Life Insurance
• Sick Time Off

At KAYGEN

We are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

Benefits

• Certifications
• Mentorship Program
• Referrals
• Family and Wellness benefits
• Continuous Growth and Career Development