Quality Assurance Engineer
Quality Assurance Engineer
To Apply: got to http://www.boydtech.com/careers
SUMMARY: The Quality Assurance Engineer promotes, develops, and oversees compliance of the company quality management system. They are responsible for ensuring implementation, execution, and documentation of quality-related processes and assuring compliance of customer and regulatory requirements by managing and maintaining quality policies, standards, procedures, and practices, while driving and facilitating continuous improvement initiatives.
- Decision Making and Judgement
- Attention to Detail
- Documentation Skills
- Accountability and Responsibility
- Project Management
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Quality Management System- 30%
- Maintain all quality records and documentation in accordance with the company’s Quality Management System (ISO 13485), FDA Registration and specific customer requirements.
- Assist in routine audits with notified bodies, customers, and supplier.
- Perform root cause analysis and determine corrective actions to address internal non-conformances, supplier non-conformances, and customer complaints. Ensure that corrective activities are implemented and documented.
- Compliance - 50%
- Work with customers, suppliers, and production to support quality requirements and ensure compliance of manufactured product.
- Maintain the ISO Class 7 and 8 Cleanroom third-party relationship for monitoring and maintaining a controlled environment.
- Support new product and process development projects as a quality representative to ensure quality and regulatory compliance.
- Assist in the creation of risk management documents with an interdepartmental team.
- Create validation and qualification protocols and reports for projects and production with the Engineering and Program Management team.
- Perform first article, in-process, and final inspections and quality line audits as needed to address continuous improvement needs on commercial production lines.
- Documentation and Records - 20%
- Maintain Certificates of Compliance and/or Certificates of Analysis and ensure quality record completion for outgoing shipments.
- Update existing work instructions and inspection forms for quality issues and/or for continuous improvement initiatives.
OTHER FUNCTIONS AND DUTIES:
- Coordinate disposition meetings for nonconforming material
- Participate in Operations, Sales, and Lean Steering Meetings
- Participate in the Safety Committee to enforce safety practices and identify risks and potential hazards
- Coordinate the calibrations of gauge equipment in the manufacturing facility
- Works with operations and business development to develop manufacturing and training methods
- Travel as needed
EXPERIENCE/EDUCATION MINIMUM REQUIREMENTS:
• Experience with MRP/ERP systems, manufacturing, and quality/continuous improvement initiatives
• Experience and understanding of the ISO 9001 or 13485 Quality Management System, or similar
Knowledge, Skills & Abilities:
- Ability to keep accurate, detailed records using good documentation practices and document control.
- Ability to follow, develop, and update documented procedures, work instructions and standard operating procedures
- Strong quantitative skills and organizational skills
- Ability to use the Boyd ERP system and electronic document management and quality records system for data entry and to generate reports
- Proficient in Microsoft Office Word, PowerPoint and Outlook applications.
- Excellent time-management skills with the ability to work independently with little supervision
- Strong communication/presentation skills and attention to detail
- Must be able to complete a post-offer, pre-employment criminal background check and drug screen.
Education: Bachelor’s Degree preferred
-OR- Any combination of academic education, professional training or work experience, which demonstrates the ability to perform the duties of the position.
About Boyd Technologies:
We're building a team of the best and brightest in advanced materials and technology solutions. We pride ourselves on being builders, solution providers, and relentless ass kickers. We're fun. We're fearless. We're resourceful. We're a small company with big goals. We believe in the power of people and understand the importance of life outside of work. We approach every day with a relentless positive attitude (RPA) that drives our success and fuels our innovative spirit. We work hard and play hard.
And we brag about our Wellness Program-because you are more than just your job and we take work-life balance seriously!
Healthy, light breakfast and snacks available to all
Cafeteria stocked with premium coffee, beer, and wine
Wellness program with lectures, training, and biomonitoring available
Individualized retirement planning and education
Corporate responsibility volunteer program
Monthly happy hours and other special events
Reimbursements for professional development and leadership activities
Continual education through internal and external training programs
14-acre headquarters’ campus with onsite trails
And here’s what else we have been up to: