Quality Engineering Manager

Overview

Serve as Quality Engineering Manager and subject matter expert for medical device products and associated manufacturing processes. This position is responsible for managing Quality Engineers and collaborating with internal departments and external contract manufacturing organizations (CMOs) to ensure compliance. Additionally, this position shall lead and support process excellence activities and ensure effective implementation of improvements on identified projects/systems. Provide similar support for quality events, CAPAs, and audit records in eQMS.

Provides audit and inspection support.

Skills: Excellent communication, presentation, time management, cross-functional collaboration skills; attention to detail, multi-tasking, experience in medical devices, and strong computer skills (Word, Excel, PowerPoint, Minitab).

Extensive experience in:

• Quality with respect to manufacturing and design
• Validation
• Design Control
• Data Analysis and Statistical Techniques
• Investigations and Root Cause Analysis
• CAPA and NC
• Lean Six Sigma tools

Experience: 10+ years in a similar role is strongly preferred, in cGMP, medical device, or regulated industry (including QA or engineering experience). Management/mentorship of personnel preferred.

Education: BS in Science, Engineering, or equivalent combination of Education, Experience and Competencies.

Preferred MS in Science, Engineering, or other related discipline

Preferred Certified Six Sigma Blackbelt or ASQ Certified Quality Engineer

• Provide Quality leadership for design control and development activities for new products and design changes.
• Serve as subject matter expert to Quality, R&D, and CMOs to lead and mentor design teams on Six Sigma techniques to be used during development and design changes (statistical sample plans, Gage R&R, DOE, process capability, reliability analysis, tolerance stack up, etc).
• Author and assist in providing design control deliverables to ensure development phase requirements are documented and compliant.
• Facilitate Six Sigma training for internal departments and external (CMOs).
• Lead risk management (Hazard Analysis, FMEA) activities for new product design and current product design changes.
• Collaborate in development of verification and validation plans and reports.
• Lead root cause analysis investigations on medical device products in conjunction with CMOs. Work with CMOs to identify and implement appropriate corrective actions to eliminate current problems and prevent future problems.
• Serve as Quality Representative for change control, quality events, CAPAs, and audit records in eQMS. Work with external CMOs to resolve technical issues as needed.
• Serve as SME for internal audits and regulatory inspections.
• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Collaborative and innovative work environment.

Disclaimer:

The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.