Morrisville, NC 27560
Salary: $66,000.00 to $80,000.00 /year
Job title Design Quality Engineer
Reports to VP, Operations
FLSA Status Exempt
Employment Status Full Time
The Design Quality Engineer will be responsible for supporting the design control activities for product development, technology transfer to operations, and ongoing sustainability activities.
Duties and responsibilities
- Responsible for providing quality-engineering support to new product development projects from conception through launch.
- Ensure product development activities are conducted in accordance with QSR, ISO13485, IVDR, and internal Quality System requirements.
- Works with cross-functional teams to assist in the development of engineering studies, design verification and validation protocols, ensuring appropriate selection of acceptance criteria, and sampling plans.
- Supports equipment qualifications by reviewing equipment specifications, IQ/OQ reports, and unscheduled maintenance reports.
- Collaborate with engineering and manufacturing teams on the development and incorporation of
- Risk Management and compliance to standards during all design phases for new products and product enhancements.
- Develop and execute human factors/usability test plans.
- Drive continuous improvement efforts through leading, facilitating and collaborating with cross- functional teams.
- Participate in FMEA processes.
- Participate in creation of inspection plans/first articles, drawing reviews.
- Responsible for auditing design history files.
- Maintain QMS procedures to ensure compliance to medical device regulations and standards related to risk management, design control, statistical techniques, usability/human factors, etc.
- Other QA duties as assigned.
Education: Bachelor of Science degree in Engineering or Science discipline
- 2+ years of experience in similar role working with R&D and Operations in a product development/design control environment.
- Experience working in a regulated medical device industry required. In vitro diagnostics industry experience preferred.
- Requires a working knowledge of design control to support and assure completion of compliant design control deliverables. Requires a thorough working knowledge of FDA’s
QSR (Quality System Regulations) and ISO 13485 standard.
- Experience in the evaluation and implementation of global standards required such as IEC 60601-1, ISO 14971, etc. preferred.
- Experience in the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, and Root Cause
- Experience in software development and software quality assurance preferred.
- Experience with configuration management is a plus.
Required Skills, abilities, characteristics:
- Strong ability to make risk-based decisions using sound judgement with appropriate level of risk/benefit.
- Statistical data analysis methods to establish sampling plans and evaluate/compute process capability required.
- Capable of ensuring compliance to standards, regulations and company procedures.
- Must be positive, energetic team player, and an advocate for product excellence and quality.
- Must be able to develop and maintain positive working relationships. Ability to coach and facilitate continuous improvement across various functions in a dynamic environment.
- Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the company.
Working conditions 1st shift with ability for some work from home.
Physical requirements N/A
Direct reports None