Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
Must Have:
Advanced Project Quality Engineering Specialist
Nice to Have:
EUMDR experience
JOB DESCRIPTION
This position will support all cardiac surgery EU MDR implementation projects to create/ review and approve change orders, redline the technical documentation, actively lead the label verification process in collaboration with quality engineers at Grand Rapids. Support all other EU MDR related deliverables for the MDR team as appropriate.
Top 3 technical skills that are required for the role:
Quality Engineer experience at medical device
Work in the fast pace environment
MDR experience is preferred
Education Required: University degree e.g. Bio medical Engineering, mechanical engineering, Biology, or similar.
Years Experience Required: 2
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 or hybrid (with mandatory 3 days onsite including Monday, Wednesday & Fridays or rotation to support when necessary)
What is your timeline for scheduling interviews? As soon as possible
What product line will this person support? Cardiac Surgery
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Accountable for the successful implementation of the outcomes the EU MDR implementation projects, EU MDR remediation assignment. Prioritization of the projects deliverables at Grand Rapids. Support label verification process, inspection, FAI, and other Grand Rapids related QE activities to move the MDR projects in a timely manner. Review and approve change orders that are related to MDR projects and ensure the quality aspect of the projects are reviewed and in compliance. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed). IQ, OQ and PQ performance and review if needed. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. 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.