Sr Supplier Qual Engineer - Exempt
Company: Artech LLC
Posted on: May 27, 2023
Job Title: Sr Supplier Quality Engineer
Location: Billerica , MA
Duration: 24 Months
Job ID: 9811
In this exciting role as a Senior Supplier Quality Engineer you will have the opportunity to work with new acquisitions across ***.
This key role will support supplier quality engineering activities including QMS integration activities and ensuring product requirements are met while maintaining product quality, safety and compliance. Our Global Quality Strategy is rooted in the *** Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life:
Support and lead QMS integration activities per *** requirements.
Support and lead Product Qualification activities ensuring suppliers can deliver quality products, materials, and services.
Assess and qualifies suppliers according to *** requirements.
Monitors products from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems before they occur.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
Lead and develop the Product Acceptance Strategy for incoming inspection and associated test method validation for all internal *** Test Methods.
Implement a Certified Supplier Program supporting Receiving Inspection to improve cost effectiveness.
Provide routine communication and updates to leadership regarding supplier activities and performance.
Top 3 things you are looking for in a candidate s experience (please be specific):
Medical Device Experience
Electrical / Mechanical background
Component / Product Qualification Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.
Education Required: Bachelors (Electrical / Mechanical / Biomedical Engineering
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 supplier related 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. Most of the 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 in-depth 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 decision making. 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.
Electrical / Mechanical Engineering
Process Validation, Change Management Processes, Statistical Analysis.
Test Method Validation
Nice to Have:
Agile MAP Experience
Incoming Inspection Methodologies
Job Title: Sr Supplier Quality Engineer
Keywords: Artech LLC, Billerica , Sr Supplier Qual Engineer - Exempt, Engineering , Billerica, Massachusetts
here to apply!