Supplier Qual Engineer II

Reference: 630791

Posted:

Location:

North Haven, CTCompany:
Planet Pharma Group Contact:
Applications Email: applications

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 FMEAsTop 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. However, I will be on vacation May 27 to June 8 but will have someone on my team review resumes and schedule interviews What product line will this person support?

Robotic Surgical Technologies support contract manufacturer

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplierrelated problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation. SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy:
Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones .

May have some involvement in cross functional assignments. Innovation and Complexity:
Problems and issues faced are general, and may require understanding of broader set of issues or…