Job description

The Quality Engineer 2 is responsible for ensuring products meet specifications and are developed and manufactured with quality and meet all applicable requirements. The Quality Engineer 2 provides expertise and leadership in areas of process engineering, product quality assurance, hardware and software quality engineering, and drive continuous process and product improvements.

Target salary rate is $83,511.00 or above, depending on years of experience and expertise.

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.
• Lead the product quality assurance and quality engineering aspects of activities to drive strong engineering and technical knowledge.
• Establish quality assurance, engineering programs, and initiatives to ensure products and assemblies are developed and manufactured according to applicable requirements.
• Work closely with Manufacturing/Operations, NKC R&D and other departments to ensure quality products and processes are developed, deployed and meet all engineering requirements. This includes product design testing, process testing and validation, characterization, qualification, hardware and software validation, risk analysis/FMEA, etc.
• Conduct investigations and provide corrective and preventive actions and complaints based on sound engineering analysis (e.g. problem solving and root cause analysis tools). Provide effective solutions that will drive continuous and measurable improvements.
• Documents work in a manner that is understandable to readers who did not participate in the investigation.
• Utilize systems for the identification, analysis, correction, and prevention of quality issues. Identifies data necessary for monitoring key processes or conduct investigations, collaborates with other functions to gather the data, and uses tools to analyze the data and drive improvements.
• Participate in CAPA Management, MRB/NCMR and other quality engineering projects as assigned.
• Participate in projects as assigned including operations and/or R&D projects.
• Collaborate with quality engineers and/or technicians as assigned and provide technical leadership in problem resolution, process streamlining and continuous improvement activities
• Adheres 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 Life Sciences, Engineering, or related discipline
• Minimum 4+ years of experience in medical device quality engineering

Competencies Required:

• Quality Engineering principles
• Critical thinking and strong problem solving skills
• Hardware and software validation principles
• Statistical Tools
• Presentation skills
• Project management
• Good Documentation Practices
• Quality System requirements within Medical Device (e.g. 21 CFR 820, ISO 13485, ISO 14971, etc.)
• Able to work effectively both independently and in a collaborative team environment

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, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested.

TRAVEL: Minimal

ACCESS to CUSTOMER SITES: Not Required

PERKS AND BENEFITS

Click here to learn more about working at Nihon Kohden America

• Paid Time-Off
• Group Insurance Plans
• FSA, HSA
• 401(k)
• Company Bonus
• Vacation Donations
• Car Allowance Program
• Wellness Program
• Volunteer Day
• NK University
• Tuition Reimbursement
• Professional Development
• Discounted Tickets
• Employee Referral Bonus up to $4,000

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.

Job Type: Full-time

Pay: From $83,511.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

Supplemental pay types:

• Bonus pay

Experience:

• quality engineer: 4 years (Required)

Work Location: One location

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