Quality Engineer II

Job Duties

• Cross Functional Team member to support new product development, product manufacturing transfers, procurement, on-going manufacturing and servicing processes representing Quality Engineering discipline.
• Completes assigned Quality Engineering tasks to schedule.
• Promotes awareness of Quality and Regulatory requirements.
• Leads or participates in the development of process and procedure development/changes.
• Applies statistical methodology to evaluate current processes and process changes.
• Develops new approaches to solve problems identified as part of the team.
• Assists in the implementation, compliance and maintenance of standards (e.g. FDA ISO 13485) and OSTA Quality policies and procedures.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Applies the requirements of the Quality System to processes, products or services for the location.
• Supports the manufacturing line to address quality issues and resolution.
• Provides support to metrology, component inspection methods and preventive maintenance programs.
• Supports validation and verification strategy for new and existing products and processes as assigned.
• Leads the development and maintenance of product Master Validation Plans.
• Participates in the CAPA process as required as a CAPA Lead or CAPA project team member.
• Investigates escalated product complaints related to manufacturing issues to root cause to ensure timely customer response and correction.
• Monitors product and process performance metrics and acts upon trends (positive or negative).
• Leads MRB as a team member to ensure proper disposition of non-conformances.
• Authors, collaborates and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling.
• Supports site regulatory inspections, internal audits or customer audits as requested.
• Interfaces with SQE function to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products, processes and services.
• All other essential duties as assigned.

Job Qualifications

Required: A minimum of a Bachelor's degree (B.S.) in science/engineering discipline. Equivalent industry experience. Minimum of 3 years related experience preferably in the medical device industry related to process/quality engineering. Knowledge of basic mechanical testing and material properties. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001, MDD93/42, ISO 13485-2016, and Canadian Medical Device requirements. Good statistical and analytical skills. Working knowledge of Problem Solving Tools: Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc. Working knowledge of Quality Tools: Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean Six Sigma, etc. Strong verbal and written communication skills in a cross-functional team environment. Demonstrated ability to generate technical reports and the ability to make presentations to middle and upper management. Proficient in the use of Information Technology and applications.

Preferred: ASQ certifications in one or more of the following areas: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).