Sr Quality Engineer

Sr Quality Engineer

Requirements

• Bachelor’s degree required in Mechanical Engineering, Electrical Engineering, Computer Engineering, or a technical field
• Minimum of 4 years of Quality Engineering experience or advanced degree with a minimum of 2 years relevant experience

Responsibilities

• 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.
• CAPA (Corrective and Preventive Action): Proficiency in leading lower risk CAPA processes to identify, investigate, and resolve quality issues; Show proficiency with the use of at least 2 Root Cause Analysis tools: fishbone, 5 whys; Being able to explain the differences between containment, correction, corrective action and preventive action;
• Project Management: Being able to lead projects and establish project plans
• Internal and External Auditing: Skills in participating in the backroom during and/or leading internal audits and managing external audits by regulatory bodies and notified bodies;
• Risk Management: Knowledge and application of risk management processes and standards independently such as ISO 14971 for identifying and mitigating risks associated with medical devices. Being able to explain the risk management structure of a product. Be able to establish and make improvements to risk management processes based on standards such as ISO 14971 and industry practices for identifying and mitigating risks associated with medical devices.; being able to train others in the risk management process and applicable standards; being able to establish the risk management structure for a product; Being able to execute Health Risk Assessments (HRA) and explain the difference between P1, P2, severity, sequence to events – coach others through the process; being able to provide guidance on statistically relevant approaches to perform the HRA; being able to establish P1, P2, severity, sequence of events for a novice product (new to the market); being able to establish, execute and communicate a remediation plan
• Internal Supplier Quality Management: Evaluating and establish criteria for internal supplier quality to ensure that materials and components meet regulatory and quality standards.
• Test Method Validation – Lead the planning and execution of test method validations following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to identify approaches to optimize the sample size. Being able to coach team members on the identification of challenge samples. Being able to provide a rationale and a plan for the TMV remediation, as needed.
• Equipment Qualification – Lead the planning and execution of equipment qualifications following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to explain the differences between IQ/OQ/PQ. Being able to collaborate with R&D on the identification of challenge samples.
• Process Validation – Lead the planning and execution of process validations following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to explain the differences between IQ/OQ/PQ. Being able to collaborate with R&D on the identification of challenge samples.
• Design verification and design validation – Being able to identify when design verification and/or validation are required per the established procedures. Being able to explain the difference between design verification and design validation. Being able to identify the statistically relevant sample size and document the rationale. Being able to collaborate with R&D on the identification of challenge samples.

Preferred Qualifications

• Strong knowledge on project/program management techniques or PMP certification or equivalent
• Experience in test automation and with statistical process controls
• Black Belt or Master Black Belt certification
• Experience with statistical process controls
• Must be self-motivated to complete assigned tasks on time.
• Must be able to multitask on several assigned projects/assignments
• Strong communication and presentation skills