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About the Role
The QMS Specialist is a member of the Operations Quality team, ensuring compliance with legal, regulatory, and international standards for Latham’s Quality Management System. This individual is responsible for documentation, process improvement, and execution of QMS procedures and work instructions to ensure controlled and compliant change.
Responsibilities
- Ensuring activities comply with Philips Excellence Process Framework (PEPF), Intra-Company Quality Agreements (ICQA), and applicable regulatory requirements.
- Managing local QMS processes and ensuring local process leveraging compliance capabilities.
- Managing the DHR review process.
- Ensuring Q&R requirements are effective in all processes.
- Document Control management for all policies and local documentation.
- Managing and monitoring the periodic documentation review process.
- Ensuring proper audit planning and schedule meets internal policies and external regulations.
- Supporting training and training administration as per the QMS.
- Contributing to training content for local QMS documents.
- Collecting and reporting metrics/KPI data to measure QMS effectiveness.
Requirements
- 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 knowledge.
- Data Analysis skills.
- Strong communication skills including written, verbal and listening skills.
- Strong organizational skills.
- Ability to multi-task and effectively prioritize workload.
- Proficient with Microsoft Office applications.
- Experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired.
- Must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
- US work authorization is a precondition of employment.
- The company will not consider candidates who require sponsorship for a work-authorized visa.
- Company relocation benefits will not be provided.
- Must reside in or within commuting distance to Latham NY.
Skills
- Quality Management Systems
- Quality Audits
- ISO9001:2015
- ISO13485:2016
- Good Manufacturing Practices (GMP)
- Regulatory
- Data Analysis
- Communication skills
- Organizational skills
- Microsoft Office
- eQMS (Trackwise, EtQ)
- ERP (SAP)
Location
- Latham NY
Work Type
- Office
- Office-based (at least 3 days per week)
Experience Level
- 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.
Education Level
- Vocational Education/ Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
Salary/Compensations
- $63,000 to $100,000 Annually
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
About the Company
- 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.
Equal Opportunity
- Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.