Quality Systems Engineer

at  Extremity Care

SKILLS & ABILITIES:

• Ability to analyze data, information, and act on results.
• Ability to work well with people at all levels within the organization.
• Accuracy and attention to detail.
• Ability to secure and maintain a favorable background investigation and clearance.

EDUCATION & EXPERIENCE:

• A minimum of a bachelor’s degree in science, engineering, other relevant discipline; minimum of 3 years of experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience.
• A minimum of 3 years of supervisory experience or equivalent.

PURPOSE:

The Quality Systems Engineer is primarily responsible for assuring product and Quality Systems compliance through the development, implementation and monitoring of appropriate processes, tools, metrics, and goals. Specifically, the Quality Systems Engineer position is the process owner for the site CAPA program, process validations, Customer Complaints, NCs, CAPAs, Internal Audits, and assigned New Product Development programs.

DUTIES & RESPONSIBILITIES:

• Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA’s, Control Plans, Procedure and Process development
• Supports investigation and resolution of Quality Events including NCs and CAPAs.
• Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
• Owner of applicable Quality Systems related NC/CAPA’s.
• Role is subject matter expert and technical advisor on the CAPA element of the site quality management system.
• Maintains current knowledge of FDA QSR, FDA 21 CFR 1271, ISO 13485, AATB Standards, and DMEPOS requirements and applies to applicable Business processes.
• Analyzes inspection and testing processes, mechanisms, and equipment.
• Develops and/or reviews product, process test equipment and/or software validation and qualification protocols and tracks execution of protocols in support of project timelines.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
• Observe and promote Company standards and policies on safety, quality, and productivity.
• Responsible for assisting/ performing necessary equipment/ process validations.
• Responsible for ensuring all environmental and product monitoring requirements are met. Assures adequate sampling plans, inspection procedures and test methods are implemented.
• Management review compliance and Quality Objective alignment.
• Creates and maintains quality indicators and respective reports/ presentations.
• Responsible for the development and training of Quality employees.
• Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
• Evaluate, implement, and continuously improve execution of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance.
• Oversee the product release to ensure that safe and effective product is distributed to customers. Responsible for approval or rejection of components, finished products, and documents to achieve this purpose.
• Maintain hazardous and biohazard waste according to EH&S procedures.
• Report to work in-person and start job duties on time for established shift.
• Complete required hours on assigned works shift to complete assigned responsibilities and duties.