Must Have:
CAPA
JOB DESCRIPTION
Quality Engineer II:
Responsibilities may include the following and other duties may be assigned.
A representative for the Released Product Management (RPM) Design Quality team on projects that address day-to-day quality issues of the market-released products.
Compliance effective oversight with the RPM activities per the applicable Standard Operating Procedures (SOP's) and External Standards as part of the process.
Contribute and lead activities during the following activities:
Risk analysis, including product risk assessment ownership, key stakeholder to various Failure Mode and Effects Analysis, and assessing specific product issues for impact to patient and/or user safety and product quality
Drawing and specification reviews
Verification and Validation testing and reporting
Product performance reviews
Test method validation
DHF audits
Mechanical drawing review and approval per ASTM-14.5Y.
Technical problem-solving compiles data and prepares reports on findings to identify trends proposes corrective action as needed.
Collaborates with RPM project cross-functional team to ensure quality standards are in place.
May specialize in RPM risk management, test method validation, and equipment calibration/qualification/validation.
Top 3 technical skills that you are required for the role:
Compliance effective support
Released product management
Test method validation
Education Required: Bachelor's degree in Engineering, Science, or technical field required
Years Experience Required: Minimum of 4 years of quality system experience
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours/week.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite.
What is your timeline for scheduling interviews? As soon as possible, this is urgent hire.
What product line will this person support? All products within ET/CST.
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for finished medical device products. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for evaluating the precision and accuracy of released products. Performs statistical analysis to investigate 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, product evaluation and reliability, research and development as they apply to product 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: 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 4 years of relevant experience, or advanced degree with 2 years of experience.