Sr. QMS Engineer

Koninklijke Philips N.V • Reedsville, WV

36d • Onsite

About The Position

Sr. QMS Engineer
In this role you
Are responsible for the deployment and proper functioning of apliant Quality Management System (QMS). The role analyzesplex QMS data, prepares detailed reports, and presents findings to leadership.
Your role:
• Takes ownership of moderatelyplex 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 rmendations for action.
• Acts as a key liaison between the QMS team and other departments to ensure effectivemunication, 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 ensurepliance 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.
You're the right fit if:
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.
Prefer experience with Quality, QMS, CAPA, Risk Management in a Medical Device.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this Office/Remote position.

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.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this Office/Remote position.

Nice To Haves

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

Responsibilities

• Takes ownership of moderatelyplex 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 rmendations for action.
• Acts as a key liaison between the QMS team and other departments to ensure effectivemunication, 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 ensurepliance 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 ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and . Details about our benefits can be found .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees