Our client, a Successful and Growing Medical Device Manufacturer with 20 sites globally is in search of a Senior Quality Engineer who wants to be part of a fast paced, dynamic medical device contract manufacturer. This site, producing wound care products, immunoassay products and other medical devices, has just over 100 Employees, over 30 injection molding machines, 10 micro molding slide machines, a few blow molders and a Class 8 clean room. The Senior Quality Engineer should have experience in a regulated industry with validation and audit experience.  This is an opportunity to be mentored to be a leader/ manager within this organization. The primary purpose of this job is to provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

 

Senior Quality Engineer Responsibilities:

 

1. Ensure all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
3. Ability to interpret drawings, product/performance specifications, and other systems integration technical data
4. Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
5. Leads product and process improvement initiatives.
6. Implements various product and process improvement methodologies
7. Reviews the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
8. Leads in the development, completion, and maintenance of risk analyses.
9. Leads generation and completion of protocols and reports for product, process, and test method validations.
10. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
11. Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
12. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
13. Leads and manage complaint investigations and remediation recommendations as needed.
14. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
15. Assists with product transfers.
16. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
17. Provides technical support to and work direction for other Quality Engineers and Quality Inspectors as needed

Senior Quality Engineer will have:

• Ability to work independently with minimal work direction and in a cross-functional team environment.
• Ability to effectively communicate written and verbally.
• Ability to manage time effectively to ensure timely completion of tasks.
• Sound knowledge of quality management systems

Senior Quality Engineer Education/Certification:

• Bachelor’s Degree in Engineering or related field or equivalent to.
• Certified Quality Engineer (ASQ-CQE) a plus

Senior Quality Engineer Experience:

• 3-5 years of experience working in a quality engineering role within a regulated industry.

Senior Quality Engineer Skills/Competencies:

• Strong communication skills with a history of positive engagements with suppliers and customers.
• Demonstrated proficiency in utilizing Statistical Analysis Techniques and Quality Tools such as (Cpk, SPC, FMEA, PFMEA, Fish-Bone Analysis, 8D problem solving, etc.) is required.
• Disciplined and effective problem-solving and influence skills proven through experience leading process and product improvement teams. Certified Six Sigma (6σ) Green Belt, Black Belt or Master Black Belt preferred.
• Must have ability to work well in a matrixed organization and adapt quickly to change.
• Project Management Experience is a preferred
• Proficient in Process Validation (IQ/OQ/PQ/Test Method/Software Validation)
• Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards specifically ISO 13485 and ISO 9001 (e.g. ISO, QSR, CFR, GxP, UL, MDD, TGA etc.)
• Internal Audit experience is preferred
• Proficient in Microsoft Office and Excel
• Experience with working in ERP systems
• Conflict resolution and team building skills are a plus
• GD&T Skills are a plus