Total Quality Senior Specialist jobs in Fitchburg, MA

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 procurement manufacturing returns and servicing of products produced. Can serve a backup as the Management Representative for the location.

Job Duties

• 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. FDAISO13485) and OGA Quality policies and procedures. Trains location personnel on all aspects of the Quality System and regulatory standards. Serves as a mentor for the Quality team to assist in developing Quality Engineering skills. 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

Job Qualifications

Required:

• Bachelor's degree in Engineering discipline or equivalent.
• Minimum of 8 years of related experience and/or training; preferably in the medical device industry related to process/quality engineering.
• Leadership experience (i.e People and Administrative Skills); ability to lead and manage cross-functional teams.
• 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.

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