Supplier Qual Engineer II

3 weeks ago

North Haven, United States LanceSoft Full time

Must Have:
1. Experience supporting, coordinating and / or leading projects 2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA) 3. Experience in development of new or existing medical devices 4. Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA
1. Investigation and root cause analysis skills 2. Technical writing knowledge. Organization and Communication skills 3. Process validation knowledge close
Change Control
GMP
PFMEA
PPAP - Purchased Product Approval Process
SCAPA
Working knowledge of change control process and project management

JOB DESCRIPTION
Top 3 technical skills that you are required for the role:
Lead, support, review, and approve supplier change requests, Validation, MSA, SCAPA, TMV, PPAP, Risk Assessment etc.
Work with new and existing Client/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including SPC, Quality Plans, Control Plans, and FMEAs
Familiar with the Medical industry requirements such as ISO 13485
Education Required: Bachelor's Degree in Engineering/Scientific/Electronic or technical field
Years' Experience Required: Minimum of 4 years of relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs
Does this position require the candidate to be onsite or remote? On site at North Haven, CT.
What is your timeline for scheduling interviews? ASAP
What product line will this person support? Robotic Surgical Technologies

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 other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

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