SR QLTY & RELIABILITY ENGINEER

Job Overview

Reporting to the Quality Manager, the Sr. Quality and Reliability Engineer is a member of the Operations Quality group. The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They will lead and work as part of a team to maintain high quality/performance standards on all TE Medical products.

The position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.

The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.

Job Requirements

• Manage the day to day activities of the team in a safe environment and be responsible for Health and Safety goals.

• Deliver on all KPIs that help the business achieve its goal.

• Lead and drive QA initiatives within area of functional responsibility.

• Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.

• Lead, coordinate & maintain risk assessment documentation e.g. FMEA’s..

• Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.

• Strategically lead new product introduction and contract reviews from a QA perspective.

• Prepare and updating Operations procedures and associated documentation.

• Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness.

• Establish inspection standards, sampling plans, and test methods.

• Report Quality metrics.

• Develop strong links with customer organizations and other project stakeholders.

• Quality review of functional area validation documentation.

• Perform and support internal and external audits to ISO and FDA requirements.

• Perform an active role in further development and continuous improvement of the Quality Management system.

• Supervision and direction of Quality personnel.

• Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.

What your background should look like

• Bachelor degree in appropriate field (i.e. Science / Engineering or related) with a minimum of 5 yrs of progressively responsible professional level experience.  MS or  higher degree is preferred.  

• Minimum of 5 years industry experience in a medical device manufacturing environment.

• People management experience

Key Requirements

• Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.

• Experience managing and leading a team.

• Strong CAPA experience.

• Strong root cause analytical and problem-solving skills.

• Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.

• New product introduction and manufacturing process transfer experience desirable.

• Demonstrated excellent organizational skills and ability to work on own initiative essential.

• Excellent written and verbal communication skills essential.

Competencies