QMS Specialist

Philips International; Latham (NY); On-site; USD 63,000 - 100,000; Full time

Benefits offered by this job

401(k) match

Paid time off

Stock purchase plan

Education reimbursement

Job summary

Philips in Latham, NY is seeking a QMS Specialist to join the Operations Quality team. You will ensure compliance with regulatory and international standards, manage documentation and DHR reviews, and execute change control to support a robust QMS.

The role requires experience with TrackWise/EtQ and SAP, plus strong analytics for KPI reporting. The incumbent will contribute to training content, drive process improvements, and ensure document control across local policies.

Qualifications

• 4+ years of experience in Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.
• ISO 9001:2015 / ISO 13485:2016 / GMP knowledge.
• Strong communication and organizational skills, with ability to multi-task and prioritize workload.

Responsibilities

• Ensure Latham site complies with Philips Excellence Process Framework (PEPF) and ICQA requirements.
• Manage local QMS processes and documentation control, including DHR reviews.
• Plan and monitor internal/external audits and drive corrective actions.
• Develop and contribute to training content for local QMS documents and report KPI data to measure QMS effectiveness.

Skills

QMS

Regulatory compliance

Data analysis

Education

Bachelor's Degree in Mechanical Engineering

Industrial Engineering

Science

Tools

TrackWise

EtQ

SAP

Job description

Job Title QMS Specialist Job Description In this role you 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. 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. undefined 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.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture.

Philips Transparency Details

The pay range for this position in Latham NY is $63,000 to $100,000 Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Latham NY. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dicta.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights