Sr Quality Engineer - Exempt

Must Have:
CAPA
Medical Device
Risk Management
RPM Quality

Nice to Have:

10+ Years design experience in medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management

JOB DESCRIPTION
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.
Specialize in RPM risk management, test method validation, and equipment calibration/qualification/validation.
Top 3 technical skills that you are required for the role:
CAPA
Medical device risk management
Compliance effective oversight
Education Required: Bachelor's Degree in Engineering, Science or technical field with 6+ years of work experience in Engineering and/or Quality
Years' Experience Required: Minimum of 6 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 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, corrective and preventive actions investigation, 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: 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 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.