6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEER

TITLE: Quality Assurance Engineer

POSITION OBJECTIVE: Assists the Quality Assurance and Regulatory Affairs Manager in regulatory compliant company-wide quality assurance department that provides all research, support, product development, and quality assurance functions required along with accurate specifications, service, and delivery of product to our customers.  Assist the Quality Assurance and Regulatory Affairs Manager in the management of the quality assurance department to support production schedules, personnel, resources and continuous improvement efforts that achieve efficient service productivity.  Assists the Quality Assurance and Regulatory Affairs Manager in the evaluation and controls to vendor reliability of goods and services.

QUALIFICATIONS:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor’s degree in industrial engineering, mechanical engineering, or business from an accredited four-year college is preferred. Associate’s degree or equivalent from an accredited two-year college/technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device manufacturing environment; or equivalent combination of education and experience. Experience in Plastic Injection and/or Blow Molding is desired.
• Must have working knowledge of the FDA 21 CFR Part 820 Quality System Regulation.
• Working knowledge of ISO 13485:2016 Standard is preferred.
• Current certified ISO 13485:2016 Lead Auditor certificate is preferred.
• Computer literate in Microsoft Office suite and experience with imputing data into database systems is a must. Proficiency in SAP is a plus.
• Ability to apply common sense understanding to carry out detailed written or oral instructions.  Ability to deal with problems involving concrete variables in standardized situations.
• Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary.
• Capable of effectively managing job-related stress and fostering productive workplace interactions.

JOB RESPONSIBILITIES:

• Assists the Quality Assurance and Regulatory Affairs Manager in developing and maintaining a complete, comprehensive, and compliant quality management system that supports the manufacture and sourcing of medical products in FDA product device classes I and II and Health Canada Class I; currently excluding FDA Device Class III and Health Canada Device Class II, III, IV products.
• Assists the Quality Assurance and Regulatory Manager with medical device company compliance to various regulatory agencies and regulations; specifically, the FDA and Health Canada: QSR and applicable cGMP’s, AMMI Sterilization Standards, OSHA, EPA and other federal, state and local regulatory agencies.
• Assists Quality Assurance and Regulatory Affairs Manager in the compliance and maintenance of the quality management system.
• Provides the quality engineering function assuring that products meet their intended use through product specification, continuous evaluation, and data analysis.
• Provides the company-wide training in statistical techniques and quality science.
• Directs technical and administrative personnel engaged in quality assurance activities.
• Evaluates and provides for audits, corrective actions, preventive actions, and compliance verification of internal and external quality management systems and their functions.
• Investigates, prepares, and maintains records for customer complaints with root cause analysis along with corrective action, preventive action, and effectiveness check.
• Acts as a quality representative for customers and vendors.
• Assures validation and compliance of our medical device products through our contract sterilization facilities and our sourced medical device products sterilization facilities.
• Acts as a quality representative for customers and vendors.
• Other duties as assigned by Quality Assurance and Regulatory Affairs Manager.

WORK ENVIRONMENT CONDITIONS SUBJECTED TO IN THIS POSITION:

• Office environment consists of a fixed or modular office that includes adequate lighting, heating/cooling, equipment and furniture in a good working condition.
• Must be able to work constructively and cheerfully in an environment that may be stressful due to adversarial situations, and at all times maintaining company as well as employee confidentiality.
• Must be able to tolerate a manufacturing environment of noise, fumes, and particulates generated from various types of plastic materials and equipment.