Quality Engineer I - Exempt

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

Nice to Have:
Approving Design Control Documentation

JOB DESCRIPTION
Top 3 technical skills that are required for the role:
Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA)
Experience in development of new or existing medical devices
Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA
Education Required: bachelors degree
Years' Experience Required: 1-3
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? Hybrid (3 onsite per week)
What is your timeline for scheduling interviews? ASAP (after Thanksgiving holiday)
What product line will this person support? Multiple, anything GST related from MDR pipeline

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.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
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.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A - job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.