QMS Specialist
Philips
Summary
The QMS Specialist is a member of the Operations Quality team in Latham which ensures compliance with legal, regulatory, and international standards as they apply to Latham's Quality Management System. This individual is responsible for documentation, process improvement, and execution of QMS procedures and work instructions to ensure change is executed in a controlled manner and in compliance with applicable regulations.
Job description
Your role:
- Responsible for ensuring that activities performed at the Latham site comply with the requirements defined in Philips Excellence Process Framework (PEPF), Intra-Company Quality Agreements (ICQA) and additional applicable regulatory requirements.
- Manage (local) QMS processes and ensure (local) process leveraging compliance capabilities.
- Manage DHR review process. Ensure Q&R requirements are effective in all processes in scope, Document Control management for all policies and local documentation. Manage and monitor periodic documentation review process.
- Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Supporting training and training administration as per the QMS and contributes to training content for local QMS documents as necessary. Collection and reporting of metrics/KPI data to measure QMS effectiveness.
You're the right fit if:
- Vocational Education/ Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
- 4+ years of experience in Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive with Vocational Education.
- 3+ years of experience with QMS in medical device, General understanding of ISO9001:2015 / ISO13485:2016 / Good Manufacturing Practices (GMP). Regulatory, Data Analysis.
- Strong communication skills including written, verbal and listening skills. Strong organizational skills, ability to multi-task and effectively prioritize your workload.
- Proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired.
- 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.
Requirements
- Vocational Education/ Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
- 4+ years of experience in Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive with Vocational Education.
- 3+ years of experience with QMS in medical device, General understanding of ISO9001:2015 / ISO13485:2016 / Good Manufacturing Practices (GMP). Regulatory, Data Analysis.
- Strong communication skills including written, verbal and listening skills.
- Strong organizational skills, ability to multi-task and effectively prioritize your workload.
- Proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired.
Benefits
- Paid Time Off
- 401(k) up to 7% match
- Health Savings Account
- Stock Purchase Plan
- Education Reimbursement
Company overview
Koninklijke Philips N.V., commonly known as Philips, is a Dutch multinational health technology company that has evolved from its origins as a consumer electronics conglomerate into a leading global healthcare solutions provider. Founded in 1891 in Eindhoven, Netherlands, Philips has transformed its business focus since the 2010s to concentrate exclusively on health technology. The company operates through three main divisions: Diagnosis and Treatment, which manufactures advanced medical imaging equipment including MRI, CT, and ultrasound scanners; Connected Care, specializing in patient monitoring systems and respiratory care products under the Respironics brand; and Personal Health, producing consumer healthcare products like electric shavers, Sonicare toothbrushes, and Avent childcare items. With 68,419 employees worldwide and annual revenues of €18.02 billion (2024), Philips maintains its global headquarters in Amsterdam while operating manufacturing, R&D, and sales facilities across 26 countries. The company has strategically divested its consumer electronics, lighting, and home appliance businesses to become a pure-play health technology organization, positioning itself at the forefront of medical innovation and digital healthcare solutions.