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Evergreen Requisition - Quality Engineer

Job Duties::
Work as a cross functional team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
Complete assigned Quality Engineering tasks to schedule.
Promote awareness of Quality and Regulatory requirements.
Participate in the development of process and procedure development/changes.
Apply statistical process control (SPC) methods to evaluate current processes and process changes.
Support the development of 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 OGA Quality policies and procedures.
Train location personnel on all aspects of the Quality System and regulatory standards.
Apply the requirements of the Quality System to processes, products or services for the location.
Support the manufacturing line to address quality issues and resolution.
Provide support to metrology and preventive maintenance programs.
Support validation and verification strategy for new and existing products and processes as assigned.
Support the development and maintenance of Master Validation Plans.
Participate in the CAPA process as required, as an assignee or project team member.
Investigate escalated product complaints to root cause to ensure timely customer response and correction.
Monitor product and process performance metrics and act upon trends (positive or negative).
Lead MRB as a team member to ensure proper disposition of non-conformances.
Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
Conduct internal, vendor, and process audits to schedule.
Interface with suppliers to resolve Quality issues.
Drive measurable Quality improvements relating to products, processes and services.
Perform all other essential related duties as required.
Job Description:
An Evergreen Requisition is an advertisement for positions that Olympus hires for throughout the year. It is a way for Olympus to build a database of qualified, interested individuals for a particular job function so that when there is a need to fill that type of role, the hiring process will be faster. By applying to an Evergreen Requisition, you are expressing your interest for a particular job function within the Olympus family of companies.
In addition to submitting your resume to an Evergreen Requisition, we encourage you to create a job search agent to be alerted when positions in your areas of interest become available. In the job search agent specify all the geographic locations you would consider.
A Quality Engineer will provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. The incumbent will represent Quality as an additional team member to support new product development, procurement, manufacturing, returns and servicing of products produced. EOE M/F/D/V
Olympus hires for the following: Quality Engineer I, Quality Engineer II, Sr. Quality Engineer, Principal Quality Engineer
Primary Hiring Locations: Bartlett, TN; Brooklyn Park, MN; and Norwalk, OH
Job Requirements::
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor?s degree in Engineering discipline or equivalent is required for all position levels.
Quality Engineer I: Minimum of 0-3 years of related experience and/or training is required; experience in medical
device industry related to process/quality engineering is preferred.
Quality Engineer II: Minimum of 3 years of related experience and/or training is required; experience in medical
device industry related to process/quality engineering is preferred.
Sr. Quality Engineer: Minimum of 8 years related experience and/or training is required; experience in the medical
device industry related to process/quality engineering is preferred.
Principal Quality Engineer: Minimum of 15 years related experience is required; experience in the medical device
industry related to process/quality engineering is preferred. Must have leadership experience in the quality field.
About Us:
Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Gyrus ACMI at http://www.gyrusacmi.com/
Company URL:
Gyrus ACMI at http://www.gyrusacmi.com/
Posting Locations:
Minnesota, Brooklyn Park, Ohio, Norwalk, Tennessee, Bartlett
Posting Title:
Evergreen Requisition - Quality Engineer
Job Family:
Engineering
Auto req ID:
701BR
701BR


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