Trumbull, United States
8 months ago
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Quality Engineer in Trumbull, CT.
Position Summary and Special Duties:
As a (an) Quality Engineer your day to day duties will consist of and may not be limited to:
This position is responsible for working between our client and our suppliers, providing guidance on product and component quality requirements; generating accurate and timely supplier quality data, trends, metrics and related reports; and determining and monitoring the effectiveness of corrective and preventive actions to resolve non-conforming issues.
Essential Functions :
- Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by policies and procedures
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Participate in audits at suppliers’ sites, covering quality system and production line capability so that a recommendation can be made on their ability to produce and deliver product. Responsible for assessment and audit reports along with recommendations, so other functions at l may make appropriate decisions on selection.
- Outline and negotiate Quality Agreements
- Prepare monthly quality data for scorecard evaluation.
- Work within NCR and CAPA process. This will include working with the supplier and various affected departments within towards the timely implementation and the verification of effectiveness of corrective actions using. Quality incident resolution may require site visits to a supplier’s facility to better understand the particular issue and provide feedback to other team members.
- Execute, jointly with supplier, continuous improvement programs.
- Meet with management to ensure consistency of supplier status and problem resolution.
- Attend Supplier Performance Reviews as needed.
- 5+ years of work experience in a Supplier Quality Engineering role or equivalent experience
- Experience working in a regulated environment (ISO 13485, 21 CFR 820, or other) Working knowledge of ISO 13485, 21CFR820, 14971
- Root Cause Analysis (CAPA/NCR) experience a must
- Project Management experience
- Experience in leading/planning Process Validation, IQ/OQ/PQ/MSA (software qualification a plus)
- Experience and Knowledge of Statistical Analysis of data and related tools
- Experience in medical device manufacturing preferred
- Advanced computer capabilities including Microsoft Office software
- Strong interpersonal, written, and oral communication skills
- Well organized; able to multi-task, prioritize, and manage multiple deliverables while working in a fast-pace environment
- Problem-solving skills and critical thinking
- Highly motivated, focused, self-starter; willing to learn and take on new responsibilities/tasks
- Travel up to 30%
- Bachelor’s degree in engineering required
- ASQ CQA or CQE preferred
- Black Belt certified a plus
- Professional Certification in a related Quality/Engineering Association.
- Duration: Direct Hire
- Location: Trumbull, CT.
- Salary: 75-85K.
- Benefits: Yes
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.