Website Olympus Corporation of the Americas
In order to be considered, all applicants must apply to our website at https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=2188&company=olympuscorP
The Quality Engineer II provides Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. They represent Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced. They review and process complaints.
* Quality department representative on cross-functional teams providing quality input for new product development procurement manufacturing and servicing processes.
* Researches changes to quality standards and regulatory requirements and reports impact to ISM business processes.
* Assist in the implementation compliance and maintenance of standards (e.g. FDA ISO13485) and ISM quality policies and procedures.
* Applies the requirements of the ISM Quality System by developing and driving measurable quality improvements relating to products processes and services.
* Develops solutions to manufacturing line quality issues. Develop and document process and procedure development/changes.
* Reviews engineering change orders for compliance accuracy and completeness.
* Creates engineering change orders.
* Applies appropriate analytical methods to evaluate current processes and process changes and develops new approaches to solve problems.
* Creates validation and verification plans for new and existing products.
* Executes acceptance tests and other test plans as needed.
* Participates in the CAPA process as required as an assignee or project team member.
* Review customer complaints for completeness and accuracy and close in a timely manner.
* Conducts internal and supplier audits and interfaces with suppliers to resolve Quality issues.
* Bachelors degree in engineering discipline or equivalent.
* Minimum of 3 years related experience and/or training; preferably in the medical device industry related to process/quality engineering.
* 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).
* 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.)
* Understands design controls and Engineering change order process Quality costs and assessment statistical methods 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 presentations for management.
* Proven project management skills.
* Proficient in the use of information technology and applications.
To apply for this job email your details to firstname.lastname@example.org