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SUMMARY:

The Senior Quality Engineer will be representing Quality in product development and product improvement initiative projects. This person will plan and lead Quality Engineering activities and support Engineering, Operations, Supply Chain, Customer Facing and other functions on applicable product quality, design control, customer complaint investigations, and risk management processes and use his/her problem-solving and analytical skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ensure design control activities are satisfied.
• Lead product related risk management activities.
• Lead investigation and analysis of failed system modules, create analysis report and provide recommendations and creative solutions for continuous quality improvement.
• Lead investigation of customer complaints and conduct problem-solving sessions for non-conforming products.
• Support product and process validation.
• Generate or apply statistical methods with appropriate risk-based justification.
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and verified.
• Define critical to quality characteristics and inspection plans for components, subassemblies, and finished devices.
• Identify and propose remediation for existing and potential quality issues.
• Ensure that product changes to existing products are conducted in compliance with Regulatory and Quality standards and have approval authority for new/modified for design and process specifications.
• Maintain expertise in both current and emerging requirements and quality trends as they relate to life science products and medical devices worldwide.
• May provide guidance and work direction to lower-level Quality Engineers.
• As a Quality Engineering advisor, provide Quality Engineering guidance and support to internal organizations, regulatory bodies, and customers (e.g., audits, questionnaires).
• Other duties as assigned.

REQUIREMENTS & QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Minimum of a BS in Engineering or Scientific discipline; MS preferred.
• Experience in Biotech instrument development and commercialization activities.
• Experience with product risk analysis and management throughout product lifecycle.
• Familiar with process validation principles, including sub-tasks of equipment IQ, OQ, PQ
• Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard, Root Cause Analysis.
• Familiarity with Kaizen and Six Sigma methodology preferred.
• CQE preferred.
• 4+ years’ experience working in the Medical Device and/or Life Science Research product industries.
• Experience interacting with regulatory agencies and notified bodies and front room audit experience is a plus.
• Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA, and DOE.
• Knowledgeable in manufacturing techniques and processes.
• Problem solving, analytical, creativity, and critical thinking skills.
• Ability to effectively influence others without direct authority and partner with internal and external customers.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• The work environment is a combination of work at the desk and in the production environment to investigate product complaints and work with the manufacturing technicians.

Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.