Sr Supplier Qual Engineer

Planet Pharma; Fort Worth (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Planet Pharma in Texas is seeking a Senior SQE to manage supplier quality for Powered Surgical Solutions. You will ensure suppliers deliver quality parts, materials, and services and lead PPAP deliverables (PFMEA, control plans, IQ/OQ/PQ).

Collaborate with cross‑functional teams on NPI projects, maintain the Approved Supplier List, and qualify suppliers per company standards. Onsite work is highly preferred: four days in the office and one day remote.

Qualifications

• Requires University Degree with minimum 4 years relevant experience, or advanced degree with minimum 2 years relevant experience.

Responsibilities

• 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 Approved Supplier List including supplier type, segmentation, agreements, and audit records.
• Qualifies suppliers according to company standards including PPAP and related deliverables.

Skills

PPAP knowledge

Supplier collaboration

Quality systems

Education

University Degree

Advanced degree

Job description

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, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product .

Required Knowledge and Experience:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.