Quality Compliance SpecialistLocation – Murrysville, PA. USA In this role you will be responsible for assuring quality & regulatory compliance of the various Philips Quality Management Systems within Hospital Patient Monitoring.
Your role: Supports Internal audit, CAPA, Quality Planning, ICQA, Quality Forums and KPI tracking where needed.Provides guidance to end users on how to correctly execute compliance processes and escalating issues appropriately when needed (i.e., CAPA, NCR/QN, Audit Finding resolution, MDR/MDV reporting, Training, Quality Planning, Management Responsibility requirements, etc.).Supports coordination and management of internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) being audited.Utilizes wide-ranging experience and uses professional concepts and company objectives to resolve complex issues in creative and effective ways.Key in identifying and supporting improvements in critical quality subsystems either directly or by working collaboratively with business partners across the organization.You're the right fit if: You've acquired 5+ years of related experience in a medical device, IVD, biologics or Pharma industry.You have a practical understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.You have at least a Bachelor of Science degree in Engineering or a related field.You have clear and effective verbal and written communication skills and excellent interpersonal and time-management skills.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.
Philips Transparency Details: The pay range for this position in Pennsylvania is $79,800 to $136,800 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.
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 Murrysville, PA., USA.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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