Sr. QMS Engineer
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.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
- US work authorization is a precondition of employment.
- For this position, you must reside in or within commuting distance to Reedsville, PA.
Nice To Haves
- Prefer 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
