Quality Engineer

Quality Assurance EngineerWorks with engineering, manufacturing, sales, and operations in providing professional quality guidance to assess, correct, and maintain the product and process quality using statistical tools, documented methods, and audits. Works in a team environment to develop and implement best practices with emphasis on defect prevention, reduction in variation and waste, and provide for continuous improvements in meeting all customer and internal requirements.Establish and/or improve product/process quality individually through team-based problem-solving efforts using industry best practice skills.Participate in MRB activities and evaluate NCRs as required. Coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of the corrective actions.Manage and write process validations including but not limited to Master validation plans, PFMEA documentation, OQ/PQ protocol and OQ/PQ reports, PPAPS, FAIR, etc.Analyze data using industry accepted statistical methods through process validation and continuous improvement activities.Review and manage internal and external change control including customer specifications.Work with operations and ERP teams for new Route and BOM approvals through Cable Builder software.Facilitate software validation plans and works with the applicable team members to draft case studies, test cases and validation reports to route to management for final approval.Support customer complaints through root cause analysis using industry standard investigation methods.Support internal, customer and registrar audits as needed.Strong understanding ISO 13485:2016 Quality Management System (QMS) requirements along with basic knowledge of CFR part 820.Ability to fully understand customer specifications and specified standardsAbility to follow guidelines that are common throughout the industry, maintain a constant focus on quality and accuracy, follow directions, and work with minimal supervisionUnderstanding of test methods and techniquesExperience working in an ISO 13485:2016 manufacturing environmentExperience working in an FDA CFR part 820 manufacturing environmentGeneral knowledge / understanding of product and process capabilities and limitationsStrong analytical and statistical knowledge, familiarity with Minitab Statistical Software preferredStrong knowledge and background in process and product validationKnowledge and background in software validation activitiesExperience working with ERP systemsProficiency in using MS Office, Internet, and e-mail.BS in Engineering, or related technical or scientific discipline1-3 years' experience in a medical device manufacturing environmentExceptional written and oral communication skillsGood time management and workload prioritizationStrong interpersonal skillsExperience working in a fast-paced Manufacturing environmentCAPA (Corrective Action / Preventive Action) ExperienceSix Sigma Training preferredThis position is not responsible for the oversight or performance management of other employees.Obey all safety rules, use caution in work activities, and continuously practice safe behaviors.Immediately report unsafe conditions/behaviors and work-related injuries to site supervision.Professional office environment requiring routine use of standard office equipment including, but not limited to, computers, phones, photocopiers, filing cabinets and fax machines. Employee will need to visit the production/manufacturing floor to speak with operators and engineers. While in the manufacturing area, may be exposed to fumes or airborne particles, moving mechanical parts and vibration. The noise level can be loud at times.Sitting for periods of time at a desk in office environment.Digital dexterity and hand/eye coordination in operation of office equipment.Working in manufacturing environment periodically to observe production.Ability to effectively communicate with customers, vendors, and or other employees via phone or in person.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.An Affirmative Action / Equal Opportunity EmployerProterial Cable America provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. As a Federal Contractor, we encourage priority referral of protected veterans under VEVRAA.