Quality Engineer

Purpose

The Quality Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics, and goals. Specifically, the Quality Engineer position is the process owner for the site CAPA program, process validations, NCRs, 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 NCR and CAPA programs ensuring compliance to procedures, facilitating or completing investigations, implementing actions and providing guidance to the team in best practices
• Maintains current knowledge of FDA QSR and ISO 13485 requirements and applies to applicable TAM processes.  Support application of international requirements into TAM processes as needed
• Assists with preparation or execution of internal, supplier and external audits as required
• 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
• Responsible for assisting/ performing necessary equipment/ process/software validations 
• Back up for ensuring all environmental and product monitoring requirements are met 
• Assures adequate sampling plans, inspection procedures and test methods are implemented
• Support Management review activities as requested
• Maintain a working knowledge of FDA 21 CFR 820, ISO 13485/MDSAP, FDA 21 CFR 1271, AATB standards, other relevant regulations/standards, cGMP/CGTP, and internal organizational policies and standard operating procedures
• Creates and maintains quality indicators and respective reports/ presentations as required
• Responsible for assisting in 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
• Support the evaluation, implementation, and continuous improvement of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance
• 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

       ·  Maintain hazardous waste according to EH&S procedures, as applicable

       · Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives

       ·  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

       ·  Perform related duties as assigned

Skills

• Ability to analyze information and act on results
• Ability to work well with people at all levels within the organization
• Accuracy and attention to detail
• Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs
• Ability to read, analyze and interpret technical procedures or governmental regulations
• Ability to communicate effectively and write reports as well as business correspondence
• Ability to secure and maintain a favorable background investigation and clearance

Qualifications/Requirements

• Bachelor’s degree in science, engineering, other relevant discipline from an accredited college or university required
• At least 3 years of experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience required
• Clearance of favorable background investigation required