Sr. Quality Engineer

Job description

Primary Function of Position This position will report through the Professional Education and Program Services (PEPS) organization. This individual will be responsible for enabling the Advanced Tissue Models team to establish optimum quality control in product manufacturing and design control through implementation of key quality metrics and implementing actions to reduce defects and meet quality objectives. The position will support design and development, material procurement, manufacturing, rework, and distribution of porcine-derived and synthetic surgical training tissue models as well as distribution of supporting equipment.

Essential Job Duties

Initial roles and responsibilities for this position will include the following: 60% involvement in supporting new product development, 25% in sustaining manufacturing operations, and 15% quality advocacy and driving continuous improvements.

Product development

Strong contributor to the planning and execution of design controls, risk management, and design verification/validation for design changes for system and subsystems. Participate in risk management process ensuring that risks are properly identified/assessed and risk management files are updated accordingly. Ensure design changes are established and implemented according to ISI standards and applicable regulations. Recommend design processes and methods to meet quality goals (DFX, etc.).

Manufacturing support

Support manufacturing processes, including failure analysis and defect/scrap containments. Ensure manufacturing activities follow procedures and comply with USDA regulations. Support development and execution of process validation and verification test plans, protocols, and reports, as needed. Maintain site level process risk management files and update as required. Support production ramp, work cross functionally on issues and drive continuous improvement projects.

Support investigation and disposition of defects, both internal and supplier related.

Quality Advocacy

Develop and apply corporate-level quality metrics. Ensure the quality system requirements are effectively established and maintained. Lead and manage quality initiatives in one or more areas of product and processes quality.

Continuous Improvement

Review line non-conformance data and identify the trends and drive the continuous improvement projects including identifying the root cause, implementation and closure. Review data proactively and take actions to mitigate issues from occurring. Support internal and external audits, including audit preparation, reviewing the front room documents and interacting with the auditors. Perform risk analysis and determine quality disposition for variance requests and non-conformances.

Approve process and document changes through engineering change orders and deviations. Escalate issues/potential issues to direct management that could impact compliance, patient safety or surgical efficacy. Ensure successful, on-time completion of department projects, communicate constraints to direct management when successful project completion is at risk. Perform deep technical failure analysis based on the physics of failure.

Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment. Performs other duties as assigned by management.

Qualifications

Required Skills and Experience

Demonstrated proficiencies of 21 CFR 820, ISO 13485 and ISO 14971 requirements for making process or design changes. Understands product risk management, experience in generating/updating FMEAs. Understands Design Controls, Change Controls, Product, and Engineering Processes. Proficient with generation and execution of Qualifications, Validation protocols and Quality Assurance Procedures. Experienced in leading root cause analyses, product containment, and rework activities.

Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram). Understands typical Excel data analysis operations (e.g. Pareto, charts, and trends). Capable of thinking independently and making decisions based on limited information. Ability to communicate effectively both verbally and in writing. Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when dealing with others Ability to work independently and handle tasks with competing priorities effectively.

Required Education and Training Bachelor’s degree in Engineering, Mathematics, Physics, Life Sciences, or related discipline. Advanced degree preferred. Minimum of 8 years (or minimum 6 years with advanced degree) of experience in Quality Engineering within a manufacturing environment, including at least 4 years in the medical device industry.