The Sr Quality Engineer ensures products meet specifications and are developed and manufactured following quality procedures and meet all applicable requirements. Provides leadership in areas of electrical engineering, quality engineering, process engineering, and product quality assurance to ensure product quality and drive continuous product and process improvements.

Essential Functions and Main Duties

• Conduct all engineering activities in compliance with FDA Regulations, ISO 13485, and other national and international quality and regulatory requirements and standards.
• Establish quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements, including ISO 60601-1.
• Lead product quality assurance, quality engineering, and electrical engineering activities.
• Work closely with local and/or international Quality Assurance, Regulatory Affairs, Manufacturing, Operations, R&D, Sales, and Marketing departments to ensure highest quality products and processes are developed, deployed and meet all applicable requirements.
• Perform design verification and validation, process validation, test method validation, and risk management activities throughout the medical device life cycle.
• Conduct investigations and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements.
• Demonstrate solid understanding of internal and applicable external policies, procedures and standards.
• Collaborate with quality engineers, technicians, and manufacturing/operations personnel as assigned to provide technical leadership in problem resolution, process streamlining, and continuous improvement activities.
• Participate in CAPA Management, MRB/NCMR, and other quality engineering projects as assigned.
• Lead, collaborate with, and educate others on technical issues.
• Works effectively with cross-functional and/or global teams, readily shares information with others.
• Adhere to all company policies, procedures, and business ethics codes.
• Duties may be modified or assigned at any time based on business need.

Qualifications

Education / Certification / Experience Required

• Bachelor’s degree in electrical engineering or related discipline
• 5+ years of experience in Medical Device Electrical Engineering and/or Quality Engineering
• Certified Quality Engineer (CQE) preferred
• Level and compensation depend on location, experience, education and skills

Competencies Required

• Design Verification and Validation (V&V), Process Validation (PV), and Test Method Validation (TMV)
• Medical Electrical Equipment requirements and testing per IEC 60601-1
• Quality Management Systems for Medical Devices per 21 CFR 820 and ISO 13485
• Risk Management for Medical Devices per ISO 14971
• Quality Engineering principles and statistical tools
• Good Documentation Practices (GDP)
• Project Management
• Effective presentation and interpersonal skills
• Excellent verbal/written communication skills
• Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English
• Able to work effectively both independently and in a collaborative team environment

Compensation

The anticipated range for this position is $108,000 to $145,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Perks and Benefits

Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America

Working Conditions

Schedule: The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company's discretion.

Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, and color vision. More specific details may be provided as needed or requested.

Travel: Minimal

Access to Customer Sites: Not Required

Nihon Kohden America's official EEO policy statement follows. In keeping with this policy, Nihon Kohden America will continue to recruit, hire, train, and promote into all job levels the most qualified persons without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Similarly, Nihon Kohden America will continue to administer all other personnel matters (such as compensation, benefits, transfers, layoffs, company-sponsored training, education, tuition assistance, and social and recreational programs) in accordance with Company policy. Nihon Kohden America bases employment decisions on objective standards as much as possible in the furtherance of equal employment opportunity.

If you have a disability under the Americans with Disabilities Act or similar law, or you require a religious accommodation, and you wish to discuss potential accommodations related to applying for employment at Nihon Kohden, please contact Human Resources.