Quality Engineer II

Reference: 631799

Posted:

Location:

North Haven, Connecticut Company:
Planet Pharma Group Contact:
Applications Email: applications

Top 3 technical skills that are required for the role:
1. Lead, support, review and approve supplier change request (SCR), Validation, TMV, PPAP, SCAPA, QMS etc.
2. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities Quality Plans, Control Plans, and FMEAs
3. Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

Education Required:

Years’ Experience

Required:

Bachelor’s Degree in Engineering/Scientific/Electronic or technical field
Years’ Experience

Required:

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience .Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs weekly

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite.

Location:

60 Middletown Ave, North Haven, CT 06473

What is your timeline for scheduling interviews? Now.

What product line will this person support?
Robotic Surgical Technologies support contract manufacturer

Must Have Technical

Skills:

* Bachelor’s degree in mechanical/production engineering with Min 9-12 years of relevant experience.

* Strong expertise in DFM&A principles and manufacturing methods for plastics, metals, and packaging components & Systems.

* Proven experience in analyzing project feasibility for cost savings and efficiency improvements.

* Proficiency in CAD – Creo/SW and PLM/PDM tools (preferably Windchill).

* Solid understanding of project management methodologies, including planning, tracking, and cross-functional collaboration.

* Strong verbal & presentation skills for effective collaboration with global teams.

* Well versed with MS Powerpoint, Excel for reports preparation, data analysis/advance operations.

* Proficient in conducting Production Part Approval Process (PPAP) to ensure compliance with technical specifications and quality standards.

* Skilled in performing detailed Root Cause Analysis to identify issues, implement corrective actions, and drive continuous improvement.

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, part/process qualification, manufacturing, QMS development, and technical quality/service/costs improvements. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAsResponsibilities may include the following and other duties may be assigned.

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment;

conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production…