Overview
QA Inspector II Jobs in Hauppauge, NY at Cipla
Senior Quality Engineer (in office – Traverse City, MI)
Description: The Senior Quality Engineer is responsible for ensuring that our internal fabrication departments and our external suppliers consistently meet our rigorous quality standards (ISO, FDA, MDR) to support the development and production of safe, effective medical devices that improve patient outcomes. Within our development process, you will be involved in how those products are dimensioned through standard tolerancing and GD&T as well as developing inspection and gauging methods internally and with our supply base. This position will be responsible for the review and approval of the supplied part approval package, Supplier Quality Agreement, Supplier Audits, and Scorecards. This individual will interact/train inspection associates on new products and improvements in inspection methods
Thompson is employee-owned and vested employees automatically receive company shares.
What You’ll Do:
Evaluate, qualify, and monitor suppliers through comprehensive quality system audits and risk assessments.
Maintain Supplier Quality Agreement, Inspection Procedures and Requirements.
Lead supplier corrective action processes (SCAR) and drive effective problem resolution.
Analyze supplier quality data to identify trends and implement preventive measures.
Review and approve supplier documentation including part approval packages, deviations, process validations, material certifications, and test reports.
Collaborate with cross-functional teams including R&D, Operations, Manufacturing Engineering, and Regulatory Affairs.
Support regulatory audits by maintaining supplier documentation for compliance with FDA, ISO 13485, and EU MDR requirements.
Support the continuous improvement initiatives with key suppliers.
Coordinate Program Management activities for new Supplied product/programs – ensuring all design control deliverables are met.
Investigate and support customer complaints, concerns and returns related to suppliers.
Support D/PFMEA, Process Flow and Control Plans.
Always promote safety in the plant.
This Might Describe You:
Bachelor’s degree in engineering, Quality Assurance, or related technical field preferred with 5+ years of quality engineering experience
Knowledge of FDA QSR (21 CFR 820), ISO 13485, and EU MDR regulations
Experience with supplier auditing, CAPA processes, and risk management
Experience with statistical analysis and quality tools (SPC, FMEA, 8D, Gage R&R-MSA)
Project management skills are strongly preferred
Manufacturing experience and/or have worked in a machining, assembly and metal finishing environment in a Quality Engineering function
GD&T and Metrology skills with the ability to use lab equipment, gauges and hand tools
Proficiency in small part fixture design is preferred
Excellent communication and negotiation skills to effectively manage supplier relationships
Strong problem-solving skills
Ability to write reports and business correspondence
Reports to: Quality Manager
Hours: Full time, Monday-Friday, 8 hour days with birthday and major holidays off
Location: Thompson Surgical Instruments manufacturing building in Traverse City
Job Type: Full-time
EEO/AA
Job Type: Full-time
Benefits:
401(k)
Dental insurance
Flexible spending account
Health insurance
Health savings account
Paid time off
Vision insurance
Schedule:
Monday to Friday
Ability to Commute:
Traverse City, MI 49684 (Required)
Ability to Relocate:
Traverse City, MI 49684: Relocate before starting work (Required)
Work Location: In person
Title: QA Inspector II
Company: Cipla
Location: Hauppauge, NY
