$80K — $100K *
Provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development, product manufacturing transfers, procurement, on-going manufacturing, returns and servicing of products produced.
* 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, IS0 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.
* 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.
* As requested by Market Quality function investigates escalated product complaints related to manufacturing issues to root cause to ensure timely customer response and correction.
* Authors, collaborates, and approves Quality System documentation including changes orders, DHF, DMR, DHR, labels and labelling.
* Interfaces with SQE function to resolve Quality issues.
* Develops and drives measurable Quality improvements relating to products, processes and services.
* Bachelor’s degree (B.S.) in science/engineering discipline or equivalent industry experience.
* Minimum 3 years related experience, preferable 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.
* ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA).
* Good statistical and analytical skills.
* Working knowledge of Problem Solving Tools (i.e. Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
* Working 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.)
* Proficient in the use of Information Technology and applications.
Valid through: 6/2/2021
$200K — $250K
4 days ago