Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints. The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality. Develops, modifies, applies and maintains quality standards and protocols.
General Responsibilities include:
1. Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.
2. Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
4. Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.
5. Supports the coordinated integration of new products into Manufacturing / Operations.
6. Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
7. Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements
8. Understanding of Quality Systems and procedures
9. Other emerging responsibilities as identified and assigned.
Department Specific:
1. Support new product development teams and being able to represent quality in cross-functional team settings.
2. Perform trend analysis, FMEA (Failure Mode and Effect Analysis) and six sigma tools.
Qualifications
Experience:
1. Experience and understanding of electro-mechanical instrumented systems.
2. Medical Device experience is desirable.
3. 5 to 8 years in the manufacturing environment with at least 2 years in a team lead role or project lead, required.
4. Ability for occasional travel to local vendors to help resolve quality issues.
5. Ability to communicate effectively across various levels of the organization.
6. Professional certifications (CQA, CQE) and Six Sigma knowledge are desirable.
7. Basic knowledge of 21CFR Part 820 Quality System Regulation and ISO (International Organization for Standardization) 9000 Standards, Six Sigma tools.
8. Good writing, data analysis and communication skills.
9. Basic Microsoft Office suite skills.
10. Effective skills in analytical thinking and problem solving.
11. Ability to perform multiple tasks and ability to effectively manage conflict.
12. BS degree in Engineering (Electrical or Mechanical) or equivalent required.
Job Quality Engineering
Primary Location US-Maryland-Baltimore
Shift First Shift / Day Job
Relocation Available No
Nearest Major Market: Baltimore Job Category: Customer Service, Customer Service, Customer Service Representative, Data, Data Analyst, Engineering, Medical Device Engineer, Manufacturing Engineer, Electrical Engineering, Quality Engineer, Electrical, Engineer, Senior Quality Engineer, Healthcare, Medical Research, Medical Device, Legal, Law, Compliance, Management, Six Sigma, Quality, Inspector, Quality, Research, Product Development, Research, Service, Customer Service
