Quality Engineer, Supplier Management

Working for Micro Systems Engineering Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices our continuing success is based on our companys corevalues - innovation quality reliability integrity teamwork and undisputed expertise - thus enabling usto inspire confidence and trust in physicians and patients worldwide. We are continually looking for talentedengineers scientists and professionals to share in our mission.

Please join us as:

Quality Engineer Supplier Management

We are seeking a Quality Engineerto play a key role in strengthening and improving supplier management practices across our global supply this position you will partner directly with suppliers to address quality concerns conduct audits and build strong relationships that ensure the highest standards of reliability and compliance.

The ideal candidate brings expertise in SMT and electronic component defects along with excellent communication skills to thrive in a crossfunctional environment. This role involves regular domestic and international travel to supplier sites working closely with BIOTRONIK affiliates and thirdparty partners worldwide.

You will lead initiatives to drive supplier quality improvements support the effective use of Quality Management Systems and ensure compliance with ISO 13485 standards. This is a highimpact opportunity to contribute to the delivery of lifesaving medical technologies while advancing global supplier excellence.

Your Responsibilities

• Leads supplier management activities including external quality audits supplier selection supplier assessment and quality supplier report cards.
• Participates in the Material Review Board (MRB). Provides the first line of evaluation on material quality assessments. Works with Quality and Component Engineering to determine acceptability of material for use.
• Leads establishment of component quality metrics sample size and inspection/test procedures. Provides component quality reporting to all stakeholders. Leads the assessment of component quality and helps develop needed counter measures.
• Manages component material control through the incoming functions including the separation of conforming and non-conforming material.
• Corresponds directly with suppliers on quality-related information and data.
• Identifies opportunities to improve and sustain supplier component quality and process effectiveness.
• Prepares training material and conducts training sessions on improvement tools.
• Reports to all levels of the organization on the status of projects and improvement goals.
• Leads component quality improvement activities. This includes supplier site audits and quality feedback to the supplier. Responsible for supplier CAR generation and closure.
• Takes ownership of Quality Management Systems related to supplier quality Corrective and Preventive Action (CAPA) monitoring and measurement of component quality management of nonconforming components and quality audits

Your Profile

Education / Experience Requirements

• Bachelors or higher degree in EE Physics Mechanical Engineering Material Science Chemistry or related technical disciplines.
• Minimum of 2 years of industry experience.
• Familiarity with defects found in high reliability electronic assemblies.
• Knowledge of data retrieval and statistical analysis methods.
• Knowledge of ISO 13485 and/or FDA CFR820 standards.
• Strong verbal written organizational time management and interpersonal skills

Additional Preferred Knowledge Skills Abilities

• Skills in auditing small size to global suppliers
• Electronics manufacturing experience.
• Statistical analysis of data.
• Strong computer skills.

Work Envronment

This role is based in a temperature controlled professional office setting which may include an office or cubicle with quiet to moderate noise level. If remote the work environment is the employees residence. Work may need to be completed on campus in a lab or manufacturing environment such as clean room or warehouse. Personal protective equipment is required in the clean room and may be needed in a lab. The noise level in the lab and manufacturing environments are quiet to moderate.