Job description
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 high impact opportunity to contribute to the delivery of life saving 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
Required profile
The ideal candidate brings expertise in SMT and electronic component defects, along with excellent communication skills to thrive in a cross functional environment. This role involves regular domestic and international travel to supplier sites, working closely with BIOTRONIK affiliates and third party partners worldwide.
Your Profile
Education / Experience Requirements
- Bachelor's or higher degree in EE, Physics, Mechanical Engineering, Material Science, Chemistry or related technical disciplines.
- 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 skillss
Additional Preferred Knowledge, Skills, Abilities
- Skills in auditing small size to global suppliers
- Electronics manufacturing experience.
- Statistical analysis of data.
- Strong computer skills.
Company description
We are seeking a Quality Engineer to play a key role in strengthening and improving supplier management practices across our global supply chain. In 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.
What we offer
This is a high impact opportunity to contribute to the delivery of life saving medical technologies while advancing global supplier excellence.
