Sr Supplier Qual Engineer

Reference: 631356

Posted:

Location:

Fort Worth, TXCompany:
Planet Pharma Group Contact:
Applications Email: applications

Top 3 technical  skills that are required for the role:
1. PPAP part qualification including deliverables such as control plans, PFMEA, IQ/OQ/PQ documents, process capability studies, and first article inspections.
2. Working with supplier and incoming inspection/metrology teams to develop inspection methods, validate test methods, and establish acceptance sampling plans.
3.

Experience with medical device quality system requirements

Education Required:

Per Sr SQE job description (Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.)Years’ Experience

Required:

Per Sr SQE job description (Requires a University Degree and 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?  Yes Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?  

Onsite highly preferred. Onsite = 4 days/week in office; 1 day/week may be remote. We might consider a remote candidate if they have skills and experience that far exceed other candidates, but I anticipate this would be a rare opportunity.

What is your timeline for scheduling interviews? As soon as possible

What product line will this person support? Powered Surgical Solutions Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Collaborates with cross-functional teams on new product introduction (NPI) projects and parts. Adds and maintains supplier information on the ASL (approved supplier list) including supplier type, segmentation, selection, agreements, and audit records.

Qualifies suppliers according to company standards including PPAP (production part approval process). Works with suppliers on qualification deliverables such as control plans, risk managment files/PFMEA, IQ/OQ/PQ documents, process capablity studies, and first article inspections. Works with supplier and incoming inspection / metrology teams to develop inspection methods, validate test methods, and establish acceptance sampling plans. Prepares, reviews, and approves change orders.

. Investigates and dispositions non-conforming material. Resolves supplier-related probelms as they occur. 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:
Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:
May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:
Problems and issues faced are difficult,…