Berlin, United States
8 months ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Sr. Quality Engineer in Berlin, CT.
Position Summary and Special Duties:
As a (an) Supplier Quality Engineer your day to day duties will consist of and may not be limited to: The position will be responsible for ensuring operational adherence and compliance to TOMZ’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.
- Corrective/Preventive Actions (CAPA):
- Responsible for CAPA system administration, tracking individual CAPAs, and, as necessary, performing work on and leading individual CAPAs.
- Complaints Investigation/Returned Materials Analysis:
- Knowledge of process(es) for investigation/analysis of returned/complaint materials.
- Nonconforming Material (NCM) Control:
- Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
- Generate Gage Non-conformance documentation and execute containment, root cause and corrective action activities.
- Supplier Quality Management:
- Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
- Lead management of Supplier/vendor Corrective Actions (SCAR).
- Internal Auditing:
- Lead efforts to ensure all internal audits are performed as scheduled.
- Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
- Documentation Control:
- Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
- Preventive Maintenance, Calibration & Metrology (Gage R&R):
- Provide direction in the selection and testing methodology for defining and collecting data to support accuracy, reliability, and capability of measurement and test equipment.
- Generate protocols and execute Equipment Qualifications and Test Method Validations.
- Generate Quality Plans for the QMS and Organizational Objectives projects.
- Lead Quality Management System initiatives and continuous improvement activities.
- Provide input on and coordinate tracking/trending & reporting of quality system metrics.
- Support site customer-requested auditing activities (Customer and Regulatory Agencies).
- Ensure compliance of all site personnel to QMS requirements.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
- Other duties and responsibilities as assigned.
- Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
- Minimum of 4-6 years’ experience in a regulated manufacturing environment.
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g., ASQ CQE, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
- Experience in effectively supporting audits by customers and external regulatory agencies.
- Duration: Permanent
- Location: Berlin, CT.
- Salary: $90-105k -
- Benefits: Yes
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.
Submit resumes to: firstname.lastname@example.org