Sr. Quality Systems Project Manager

We are seeking a seasoned and strategic Quality Systems Project Manager. This is a non-people leader role. The Quality Systems Project Manager role will lead a quality system value stream to achieve excellence in safety, quality, delivery, and cost in a medical device manufacturing environment. This role is responsible for developing processes to ensure suitability of key customer accounts, non-conformance investigation/CAPA, complaints, scorecards and KPI trending, and internal / external audits.

This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions.

• Lead complex quality projects, including validations, root cause investigations, and CAPA’s for multiple medical device product lines.
• Manage and standardize customer requirements while communicating with internal / external stakeholders.
• Manage the analysis and investigation of products complaints and non-conformances
• Drive solution plans to completion by working with a cross functional team
• Set Direction and Drive Results
• Clearly communicate goals and expectations from key customers with internal team.
• Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance.
• Maintain cost controls, creating cost effective use of resources, and ensuring quality.
• Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses.
• Support training, internal and external audits, including FDA, ISO and Customers.
• Additional functions may be added at discretion of Management.

• Strong leadership and team-building skills
• Problem-solving and decision-making ability under pressure
• Proficient in interpreting production metrics and KPIs
• Comfortable providing briefings at all levels of management.
• Excellent organizational and time management skills
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, Teams, etc.)
• Strong organizational and multitasking abilities
• Ability to maintain discretion and handle confidential information professionally

• 10 plus years of experience in manufacturing or production operations, preferably within the medical device or pharmaceutical industry
• Minimum of 5 years in a leadership or project management role, ideally within a value stream or lean manufacturing environment
• Experience with FDA QSR (21
  
  CFR
  820), ISO 13485, GxP and validation processes preferred

• Education
  :
  Bachelor’s degree in engineering, science or equivalent technical experience.
• Licenses/Certificates
  :
  Industry Quality Certifications (i.e., ASQ, PMP)
• Technology/Equipment
  :
  Microsoft Office Applications, Warehouse Management Applications, eQMS software

• Ability to sit or stand and move within an office environment for extended periods of time
• Must be able to occasionally lift and/or move up to 20 lbs.
• Ability to wear Personal Protective Equipment as required
• Visual acuity to inspect parts, read documents, computer screens, etc.
• Ability to hear and verbally communicate clearly in meetings, on the phone, and in group discussions
• Occasional bending, stooping, or reaching during on-site activities or workspace organization.

• Office-based role with regular interaction in manufacturing and cleanroom environments
• Monday – Friday, standard business hours with flexibility as needed to meet project milestones
• Frequent interaction with machinery, tools, and production materials

• This position will be reports to the Director of Engineering & Quality