12319BR

Title:

Sr. Engineer, Supplier Qlty

Job Description:

Work in a team environment with suppliers to develop and implement best practices that emphasize defect prevention and reduction in variation and waste and provide for continuous improvements in meeting all customer requirements. Investigate, analyze, and resolve supplier quality issues by conducting audits, manufacturing line assessments, analyzing defect trends, and leading continuous improvement projects. Manage customer specific requirements and offer technical support to suppliers. Responsible for ensuring that the products meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are adhered to. Act as a partner in developing key suppliers (second sourcing) to meet MicroVention’s stringent quality requirements. Job duties:

• Perform analysis and identify trends in the inspection of finished products, in-process materials, raw materials, and recommend corrective actions when necessary.

• Perform problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of defects.

• Utilize process improvement tools to drive process and product quality.

• Monitor supplier quality levels and perform development activities with strategic suppliers to ensure quality performance goals are met.

• Perform supplier re-evaluations based on company requirements.

• Initiate action at the RI lab or manufacturing lines to prevent the occurrence of any non‐conformities relating to product, process, and quality systems.

• Maintain approved supplier list updates based on company requirements.

• Perform supplier quality audits.

• Develop projects to improve RI and Release capabilities.

• Develop and execute Test Method validations for RI and Release inspections.

• Develop and execute Software and equipment validations.

• Supplier process qualification - ensure supplier adherence to Work Instructions, Process Control Plans, Engineering Drawings, and Specifications.

• Work closely with suppliers and R&D, Supply Chain, and Quality Engineering groups to ensure potential suppliers (second sourcing) for development projects meet requirements for qualification.

• Generate a monthly Supplier Performance Report including input from NCRs, SCARs, and supplier ratings.

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

• Perform additional duties as assigned.

Auto req ID:

12319BR

Location:

Alajuela, Costa Rica

Department Name:

3211-CR-Quality

Qualifications:

1. Bachelor’s degree in engineering related field or equivalent, and at least 40% of studies on advanced degree.

2. Minimum of five (5) years of experience in a quality engineering role.

3. Minimum of five (5) years of experience medical device industry.

4. Strong written and verbal communication skills.

5. Expertise/experience in root cause analysis, corrective/preventive action methods, and problem solving with quality tools such as Six Sigma / 8-D/ CAPA / FMEA / 5 WHYs, etc.

6. Understanding and interpretation of engineering drawings.

7. 80% English proficiency both written and verbal.

8. Proficient with MS Word, Excel, Outlook, and Teams.

Desired Qualifications

1. Lead Auditor of ISO13485 or equivalent preferred.

2. Solid understanding of receiving inspection and finish product release processes including statistical sampling, test method validation, component measurement techniques, specifications, sterilization, and drawings.

3. Quality Certification or training on CQE, SSGB, or equivalent.

4. Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, QSR, MDD preferred.

External-Facing Title:

Sr. Engineer, Supplier Qlty

Posting Country:

Outside US

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.