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Senior Quality Engineer

Req ID:  4116

Working Location: Washington, Seattle 

 

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. Represent's 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. o 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. FDA ISO13485) 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 and validation and verification strategy for new and existing products and processes as assigned.

 

* Provides support to metrology and preventive maintenance programs.

 

* 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 Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree in Engineering discipline or equivalent. 

 

* Minimum eight 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.

 

* 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.)

 

PREFERRED QUALIFICATIONS:

 

* 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. 

 

* Working knowledge of problem solving skills – good statistical and analytical skills.

 

* 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.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

 

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

 

Posting Notes: || United States (US) || Washington (US-WA) || Redmond || 


Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue

Job Segment: Quality Engineer, Senior Quality Engineer, Manufacturing Engineer, Engineer, Engineering, Quality

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