We are seeking a seasoned and strategic Quality Systems Project Manager. This is a nonpeople leaderrole. 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. The ideal candidate embodies our values of passion, trustworthiness, result-oriented, and togetherness using them to guide effective impactful outcomes. This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions.
Essential Job Functions:
- Project Management
:- 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.
- Collaboration:
- 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.
REQUIREMENTS
SKILLS:
- Strong leadership and team-building skills
- Excellent written and verbal communication
- 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
EXPERIENCE:
- 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 (21CFR820), ISO 13485, GxP and validation processes preferred
EDUCATION:
- 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
PHYSICAL DEMANDS:
- 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.
WORKING CONDITIONS:
- 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
REPORTING STRUCTURE:
This position will report to the Quality Manager.