Senior Quality Engineer

We are conducting a confidential search for a Medical Device Quality Engineer for a premier client in the North Dallas, TX area.  This is an opportunity to join an outstanding team working to produce world-class engineered and manufactured medical devices.  This opportunity offers a competitive base salary, bonus, and benefits in addition to a great work environment.

Quality Engineer, QE, SQE, RAQA, QARA, Quality Systems, design

IF YOU MEET THE FOLLOWING 4 MANDATORY REQUIREMENTS, WE SHOULD PROBABLY SEE YOUR RESUME:  

1.       BS Degree required.  Advanced degree preferred.  Strongly  prefer ASQ Certified Quality Engineer or CQE. 

 

2.       Willingness to relocate to or ability to commute to the North Dallas area.  There is limited relocation assistance of up to $5,000 for this position.

 

3.       Minimum 5-years medical device quality.  You should have experience with medical device design control and possess strong statistics knowledge.  Six Sigma experience is key to this position.

 

4.    Demonstrated knowledge of FDA regulations, cGMPs, FMEA, DOE, CAPA, and Validation protocols IQ, OQ, and PQ.  Knowledge of various engineering drafting programs such as SolidWorks or Pro Engineer useful.

 

Below is a sample job description.  An actual job description will be presented to highly qualified candidates.

Quality Engineer

Supports new product development and product manufacturing through the application of Quality engineering skills for medical devices. This person will handle multiple projects and tasks, from product inception through product launch and process manufacturing.  Additionally, this individual will play an active role in the processes to ensure products meet quality standards consistent with company policies, while meeting all design control and other regulatory requirements.  Additionally,  the Quality Engineer will represent Quality on project teams for both Design and Manufacturing. This role also supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability and customer satisfaction and supports Quality System implementation.

 

• Participate in the development projects to help ensures products and processes are designed, developed and transferred to meet appropriate regulations and business outcomes

• Communicate significant issues or developments identified during quality activities and provides recommended process improvements to team or management.
• Leads and participates in CAPA teams in resolving production and customer issues. Dispositions any materials and components that are rejected for non-conformance with effective corrective and preventive actions
• Lead and participates in audits and assessment of the manufacturing operations, and recommends CAPA and process improvements.
• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities.  Uses Minitab or other statistical analysis software to produce reports.

• Manage assigned product lines and manufacturing processes to ensure highest product quality and assure compliance to internal and or external specifications and standards

• Establishes and maintains quality system policies and performs other related duties as assigned.

 

THIS IS AN URGENT SEARCH AND YOU ARE ENCOURAGED TO APPLY IMMEDIATELY IF INTERESTED AND QUALIFIED.  If you do not have an updated resume, please send us your old one, and give us a paragraph or two on what you have been doing most recently.

Hiring Authorities, Inc., is a global recruiting firm specializing in the Medical Device, Pharmaceutical, Biotechnology, and related industries.  We place multiple candidates each month at World Class companies.  More information on us may be viewed at WWW dot HIRINGAUTHORITIES dot COM or in MEDICAL DEVICE and DIAGNOSTIC INDUSTRY   MDDI magazine.

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