Quality Engineer II

Job Description

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.

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 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.
• 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.
• As requested by Market Quality function 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 nonconformances.
• Authors collaborates and approves Quality System documentation including changes 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 or equivalent industry experience.
• Minimum of 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.
• 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.)
• 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 is preferred but not required: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).