Sr. QMS Lead

Philips • Brown Township, PA

11h • Onsite

About The Position

Sr. QMS Engineer
In this role you
Are responsible for the deployment and proper functioning of a compliant Quality Management System (QMS). The role analyzes complex QMS data, prepares detailed reports, and presents findings to leadership.
Your role:
• Takes ownership of moderately complex processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements.
• Analyzes and interprets QMS performance data to identify trends, process inefficiencies, and potential areas for improvement, and presents findings to management with recommendations for action.
• Acts as a key liaison between the QMS team and other departments to ensure effective communication, collaboration, and alignment of QMS activities with business objectives and regulatory requirements.
• Provides expert guidance and support to project teams in developing quality plans, risk assessments, and process validations to ensure compliance with QMS and regulatory expectations.
• Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

Requirements

• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• 7+ years of experience with Bachelor's OR Minimum 5 years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.

Nice To Haves

• experience with Quality, QMS, CAPA, Risk Management in a Medical Device.

Responsibilities

• Takes ownership of moderately complex processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements.
• Analyzes and interprets QMS performance data to identify trends, process inefficiencies, and potential areas for improvement, and presents findings to management with recommendations for action.
• Acts as a key liaison between the QMS team and other departments to ensure effective communication, collaboration, and alignment of QMS activities with business objectives and regulatory requirements.
• Provides expert guidance and support to project teams in developing quality plans, risk assessments, and process validations to ensure compliance with QMS and regulatory expectations.
• Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level