- Bachelor’s degree in Engineering discipline or equivalent.
- Up to three years related experience and/or training; preferably in the medical device industry related to process/quality engineering.
- Knowledge of basic mechanical testing and material properties. Knowledge of metrology.
- Familiar with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements.
- Formal education in problem solving skills good statistical and analytical skills.
- Knowledge of Problem-Solving Tools (i.e. Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
- Knowledge of Quality Tools (i.e. 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.)
- Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management Proficient in the use of Information Technology and applications.
- Cross Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
- Completes assigned Quality Engineering tasks to schedule.
- Promotes awareness of Quality and Regulatory requirements.
- Participates in the development of process and procedure development/changes.
- Applies statistical process control (SPC) methods to evaluate current processes and process changes.
- Supports the development of new approaches to solve problems identified as part of the team. Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA 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 and preventive maintenance programs.
- Supports validation and verification strategy for new and existing products and processes as assigned.
- Supports the development and maintenance of Master Validation Plans.
- Participates in the CAPA process as required as an assignee or project team member.
- Investigates escalated product complaints 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, etc.
- Conducts internal, vendor, and process audits to schedule.
- Interfaces with suppliers to resolve Quality issues.
- Drives measurable Quality improvements relating to products, processes and services.
- All other essential related duties as required