QMS Specialist

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

Job summary

Philips Iberica SAU is seeking a QMS Specialist to join the Operations Quality team in Latham, NY. You will ensure compliance with regulatory standards, manage documentation, and drive QMS improvements to enable controlled change.

The role requires a Bachelor's or equivalent, 4+ years of QMS and audits experience in regulated industries, plus proficiency with MS Office and eQMS/SAP. Onsite with 3 days in office guidance.

Qualifications

• Vocational Education or Bachelor's degree in Mechanical/Industrial Engineering or Science.
• 4+ years of experience in Quality Management Systems and Quality Audits in highly regulated environments.
• 3+ years of experience with QMS in medical devices; knowledge of ISO 9001:2015 / ISO 13485:2016 / GMP; regulatory data analysis.
• Strong communication and organizational skills; proficient with MS Office; experience with eQMS and ERP software.

Responsibilities

• Manage local QMS processes and ensure process leveraging compliance capabilities.
• Manage DHR review process; ensure Q&R requirements are effective in all processes.
• Document Control management for all policies and local documentation; monitor periodic review.
• Ensure audit planning and scheduling meets internal and external regulatory requirements.
• Support training and training administration according to QMS; contribute to local QMS document content.
• Collect and report metrics/KPI data to measure QMS effectiveness.

Skills

Quality management

Regulatory compliance

Quality audits

Document control

Communication skills

MS Office

TrackWise

Education

Bachelor's degree in Mechanical Engineering/Industrial Engineering/Science or equivalent

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.
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• 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 witheQMS(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

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.