Job Snapshot
Location:
confidential, OK
Industry:
Medical Equipment
Manufacturing
Job Type:
Engineering
Manufacturing
Experience:
5 to 10 years
Contact Information
Description
We are seeking a Quality Assurance Engineer who, as a direct report to Quality Assurance and a member of the Product Development team, follows quality assurance and product development guidelines and procedures to ensure that developed and marketed products comply with quality, regulatory, and engineering requirements.
The ideal candidate will:
- Provide quality engineering support to the product development team. Working closely with R&D, Marketing, and Operations to develop and implement appropriate risk management, qualification, verification, and validation plans.
- Review and approve documents that support product development activities, including; design input/output; design verification; design validation; traceability analysis; risk analysis; packaging protocols; and reports.
- Participate in design, phase, and stage gate reviews to support assigned development projects and ensure all generated documentation is compliant.
- Provide guidance in the early selection and assessment of suppliers.
- Lead problem solving efforts to identify and resolve new and recurring quality issues to ensure developmentand production of safe and effective medical devices.
- Prepare and review qualification and validation test plans and reports for assigned projects, including, if required, reliability assessment. Assure the resolution of issues raised by the testing.
- Develop, implement, manage, and track effectiveness of corrective action plans and compliance improvement initiatives.
- Perform statistical analysis of data and writes technical reports.
Requirements
Knowledge and Skills
- Working knowledge of Product Development life cycle from feasibility through product retirement including design verification and validation, product release, configuration management, risk management, reliability testing and post market surveillance.
- Working knowledge of Good Manufacturing Practices, Quality Systems, Regulatory requirements, design validation principles, and manufacturing methods in Medical Device regulated environment.
- General knowledge of FDA 21 CFR 820 Quality System Regulation, ISO 13485 2003, Medical Device Directive 93/42/EEC, ISO 14971 2007.
- Knowledge of policies and procedures involved in managing an organization's risk exposures.
- Strong project management skills.
- Strong mathematics, statistical and mechanical aptitude skills.
- Effective communication skills through reading, writing and verbal media.
- Ability to analyze, estimate and evaluate.
- Computer skills - Microsoft Office.
- Ability to multi-task.
- Ability to work without direct supervision
This position requires a Bachelor of Science Degree in Science, Engineering, or related discipline. 5-10 years experience as a Quality Engineer in the medical device or comparable regulated industry. ASQ certification as CQA, CQE, or CRE would be a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accomodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee is required to walk; use hands to finger, handle or feel; reach with hands and arms; talk and hear. The employee is occasionally required to stand, bend, stoop, twist, and climb stairs several times a shift. The employee must frequently lift and/or move up to 10 pounds and occassionally lift and/or move 25 or more pounds. Visual acuity with correctable vision of 20/40 is necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
Personnel must be able to pass drug screening in compliance with Tennessee Drug Free Workplace Program.
Hepatitis B series shot may be required.
The work environment characteristics described here are representative of those an employee may have to encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occassionally exposed to moving mechanical parts, mild chemicals, and airborne particles, thus safety glasses and gloves may be required. The noise level in the work environment is moderate.
