Quality Sr Engineer I

Job SummaryResponsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals. Principal Duties and Responsibilities· Formulates procedures, specifications, and standards for Zimmer products and processes. · Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance. · Develops and implements corrective/preventative action plans · Collects and analyzes data for gauge and product evaluation. · Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer Biomet. · Perform audits of suppliers based on FDA’s QSR, ISO 13485, CMDR and any other applicable regulations as per established audit schedules and communicate results to Biomet management · Perform internal and external quality audits. · Assist in the Vendor Certification Program. · Create validation protocols, reports and execute protocols related to environmental monitoring. · Assist and/or perform in the Pilot, Qualification, and Validation Runs. · Review and approve lot, Qualification, and/ or Validation Documents · Evaluate new products or processes in order to establish the required controls to comply with the corresponding regulations and/or standards. · Review engineering change requests for product documentation, working instructions, and EQS procedures. · Review changes to PR Operational Guidelines · Evaluate and review material, product and process deviations and participate in the definition and implementation of the corresponding corrective actions. · Evaluate product non-conformances and participate in the disposition of product. · Perform/Participates of the Health Hazard Evaluations for the product · Assist and or perform Process FMEA. · Evaluate and review customer complaints and participate in the definition and implementation of the corresponding corrective actions. · Coordinate the issues, reviews, and completion CAPAs · Owner of Procedures related to the quality system. Generate necessary changes to maintain up to date with regulations and industry standards. Formulates procedures, · Perform any other special project or duty assigned by the Quality Manager. Expected Areas of CompetenceTo 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.

• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Microsoft Office Suite, Minitab, knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods,. Knowledge of statistics, process control, and process capability

Education/Experience Requirements• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).

• Certification as a quality engineer or Black Six sigma (e.g. CQE or BBSS), the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred
• 5-7 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
• Experience with Risk Analysis, CAPA Investigation and Statistical Techniques preferred. Combination of education and experience may be considered (in evaluating experience relative to requirements)

Travel RequirementsUp to 20%