PURPOSE/SUMMARY (Brief overview of why job exists, general purpose of position)

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, procurement, manufacturing, returns and servicing of products produced.

PRIMARY DUTIES AND RESPONSIBILITIES (List of 8 # 10 key tasks required of the job which are essential to the performance of this job)

• 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.
  • Leads or participates in the development of process and procedure development/changes.
  • Applies statistical process control (SPC) methods to evaluate current processes and process changes.
  • Develops 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 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.
  • Leads 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.
• Develops and drives measurable Quality improvements relating to products, processes and services.
• All other essential related duties as required

SUPERVISOR RESPONSIBILITIES (If the position has responsibility for the direct hire, discipline, and budget of subordinate jobs, list subordinate job positions and number of employees in each position. For example: Product Managers (2))

• None

MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Bachelor’s degree in Engineering discipline or equivalent.
• Three to eight 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.
• Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, 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).
• Working knowledge of problem solving skills, 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.)
• Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management
• Proven Project Management skills.
• Proficient in the use of Information Technology and applications.

PHYSICAL DEMANDS (e.g., expectations of such items as weight needed to move or lift)

• Stand/Sit/Walk 8 hrs a day

WORK ENVIRONMENT (e.g., excessive or non-standard expectations/potential exposure related to such things as heat, cold, noise or travel)

• Chemicals/Solvents
• Clean Room Infectious
• Disease exposure