Quality Engineer II (Onsite)

Working Location: MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Onsite

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

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 and 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 methodology to evaluate current processes and process changes. Develops new approaches to solve problems identified as part of the team. Assists in the implementation compliance and maintenance of standards (e.g. FDA ISO 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 OHR 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 Qualifications

Required:

• A minimum of a bachelor's degree (B.S.) in science/engineering discipline or equivalent industry experience. 
• Minimum of 3 years of related experience preferable in the medical device industry related to process/quality engineering.

 

Preferred:

• 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 t