Senior Quality Engineer
E4D Technologies LLC, 650 International Parkway, Richardson, TX 75081
Implement, maintain, and improve corporate wide quality management systems and support processes. Proactively manage the various elements of the quality systems to ensure compliance with applicable national and international quality systems regulations. Drive product quality improvements through Corrective Action or other mechanism to ensure the use of appropriate root cause analysis tools. Facilitate and manage quality strategies development, quality planning activities, risk management use, design and process FMEAs, hazard analysis, verification/validation strategy development and execution (e.g. test method validation, software validation, process validation, design verification and validations). Provide leadership to project team members in the use of data analysis tools (e.g. descriptive / interferential statistics, Minitab, DOE, Six sigma tools etc.). Represent the company during agency, notified body or other 3rd party audits and in vendor related issues. Interact with the supplier and perform supplier audits. Provide hands-on ownership for the various elements of quality systems including document control, corrective action, customer complaints, and internal audits to ensure successful performance during third party audits. Ensure various activities related to the new product introduction are complete. Perform reliability testing for new products, and regression testing of new software. Write and execute verification and validation protocol. Write and execute IQ, OQ, PQ protocol. Design history file requirements. Perform first article and incoming inspection of PCBs, mechanical, plastic and optical parts. Utilize basic knowledge of CMM, and actively manage the implementation, maintenance, and improvements of quality systems based on established direction and priorities. Ensure efficient and effective processes and tools are established for compliance with QSR requirements and are continually improved. Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific processes by guiding cross-functional teams in good documentation practices, document formatting and structure; coordinate training and communication with various departments to ensure awareness and understanding of the QMS; plan and coordinate gap analysis exercises and provide advice on bridging the gap; and assist other departments in establishing and mining databases to support quality and management objectives. Prepare regular performance reports and metrics for QMS.
Master’s degree in Engineering, Business Management, or related field and 2 years of progressive, post-baccalaureate experience in the job offered or related occupation in product assurance/quality assurance in the medical device industry. Will also accept a Bachelor’s degree in Engineering, Business Management, or related field and 6 years of progressive, post-baccalaureate experience in the job offered or related occupation in product assurance/quality assurance in the medical device industry, or any suitable combination of education, training and/or experience.
Experience must include:
1) Two years of experience in an FDA regulated and ISO 13485 certified organization in the medical device industry.
2) Certification as a Lead Quality Auditor.
3) Two years of experience conducting and participating in Customer, corporate and supplier audits.
4) Two years of experience with electrical, mechanical and electro-mechanical design.
5) Two years of experience and demonstrated working knowledge of quality systems requirements.
6) Two years of experience presenting and reporting on quality metrics to executive level management.
7) Two years of experience in optical design with small device.
8) Two years of experience of working with laser class up to 3b.
9) Two years of experience working with cGMP including IQ, OQ, PQ, TMV.
10) Two years of experience working with regulated design control that included Hazard analysis, verification and validation, manufacturing validation, labeling, dhf compliance, design review, design transfer.
11) Two years of experience working in manufacturing control including defining inspection plan, first article inspection, programming CMM equipment.
12) Two years of experience leading projects and teams.
13) Excellent interpersonal skills with all levels of employees.
This position qualifies for an employee referral bonus. If you are an E4D employee and would like to recommend someone for this position, please let us know. Check your Employee Handbook for more details!