Quality Engineer II at Olympus Corporation of the Americas in Brooklyn, MI
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. 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. 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. 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 non- conformances. 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 Requirements REQUIRED QUALIFICATIONS 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. PREFERRED QUALIFICATIONS 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.). 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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.). 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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