Share this Job

Job Title:  Senior Quality Engineer

Req ID:  31055
Job Category:  Quality

Syston, LEC, GB, LE7 1PF

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Senior Quality Engineer will report to the Quality Director. The post holder will deputise for the Quality Director as and when required.

The position is responsible for developing, maintaining and improving the quality system in accordance with the requirements of ISO13485, US FDA QSR and STERIS policies.

Duties

  1. To provide Quality support of new product development.
  2. To maintain complaint and CAPA processes.
  3. To have reporting responsibilities of other Quality team members.
  4. To implement, maintain and improve Quality Management Systems and processes in accordance with the objectives of the Organisation.
  5. Investigates opportunities for improvements and implements improvements in line with the Organisation’s objectives.
  6. Conducts Internal Audits and External Audits as required.
  7. Represent the quality team on projects to ensure compliance with QMS’s.
  8. To support the Organisation’s relationship with Customers and regulators from a Quality viewpoint. To represent the Organisation’s image as being one of high integrity at all times when representing the Organisation both internally and externally and behave in a manner both on and off duty befitting the Organisation’s image and standards.

Duties - cont'd

  1. To represent the Quality Director when required and have authorities in accordance with the Authorising Signatories process as defined in the Quality Management system. 
  2.  To represent the Organisation’s image as being one of high integrity at all times when representing the Organisation both internally and externally and behave in a manner both on and off duty befitting the Organisation’s image and standards.

Any other duties which can reasonably be expected of the post holder given their knowledge, position, skills and experience.

Education Degree

  • Vocational/Technical

Required Experience

  1. Min 5 years working experience of ISO13485, FD QSR QMS or similar QMS
  2. Min 5 years working in a manufacturing environment.

 

Preferred Experience

Skills

  1. Able to manage a busy workload.
  2. Good problem solving ability and root cause identification skills.
  3. People Management.
  4. Able to communicate to all levels within the organization.
  5. Will have a working knowledge of ISO 13485, FDA QSR or similar quality systems.
  6. Will have a good working knowledge of complaints and CAPA processes within a medical device QMS or similar quality management system.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  31055
Job Category:  Quality

Syston, LEC, GB, LE7 1PF


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