Senior 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. 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:

o Lead complex quality projects, including validations, root cause investigations, and CAPA’s for multiple medical device product lines.

o 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:

o Clearly communicate goals and expectations from key customers with internal team.

o Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance.

o Maintain cost controls, creating cost effective use of resources, and ensuring quality.

o Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses.

o Support training, internal and external audits, including FDA, ISO and Customers.

o 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 be reports to the Quality Manager