Job Title
Quality Risk Management Leader
Job Description
Quality Risk Management Leader (U.S. Hub based, EST or CT time zone)
The Quality Risk Management Leader will support Quality Management System (QMS) activities and projects for Philips Enterprise Informatics business across multiple global sites. You will formulate and implement the Business’ long range Risk Management policy and will lead and direct organizational development and processes. You will drive improvement to ensure Business strategic policy and strategic growth targets are met.
Your role:
- Enforces simplified quality systems and harmonizes them across the supported business sites. Introduces and implements the quality processes and tools required to ensure product quality and customer satisfaction.
- Manages compliance with FDA regulations and other Regulatory Agencies as required. Ensures guidelines and policies to all products and operations are consistent with those regulations. Interact with all areas involved in the product development process and launch to provide direction and consultation. Ensures that all products to be released comply with all relevant safety and environment policies and regulations by implementing requirements, conditions and enables in the Business.
- Regularly interacts cross-functionally with various stakeholders at all levels of the organization. Ensures the policy establishing safety risk acceptability for each product is created, approved, and maintained by top management, as well as product safety risk management deliverables, and includes storage in the Risk Management File during product development.
- Monitors and reports on the products’ safety risk management performance in the field and ensures deliverables are updated as needed. Ensures product risk assessments are performed as needed after product launch. Collects and reports KPIs as described in the Product Safety Risk Management process.
- Capable of performing detailed quality engineering tasks such as assessing product designs and reviewing test and other performance data, analyzing market feedback, completing or assisting with root cause analysis and quality problem solving. Support efforts to improve effectiveness and efficiency of the post-market process. Collect, analyze, and disseminate quality data throughout the organization.
- Identify opportunities or detections within the process through statistical analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution. Participate in areas such as Corrective/Preventive Action program (CAPA) and Internal/External audits.
- Comfortable traveling up to 15% annually, domestic, and international possible.
You are the right fit if:
- You have acquired 10+ years of broad experience in Quality Management and Risk Management experience. You also have experience leading audits, proven ability to work independently as a decision-maker.
- Your skills include experience collaborating with local stakeholders for the proper adaptation of quality system processes and driving common Quality & Regulatory goals and objectives towards improved customer experience, operational excellence & dedicated regulatory compliance.
- You have an in-depth knowledge of relevant medical device industry standards such as ISO 13485 and ISO 14971. Experienced with Corrective and Preventive Actions (CAPAs) and audits in a medical device setting. Bachelor’s degree in a relevant scientific or engineering field or higher is preferred. Will consider candidates with equivalent relevant experience and education.
- 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.
- You have an ability to influence without expressed authority, have a strong accountability for results achieved, and a strong passion for patient safety & quality. The ideal candidate will be viewed as an expert in Risk Management but with a broad background in the Quality Management field as it pertains to the medical device industry. Strong product knowledge is also desired.
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.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details
The pay range for this position is $104,300 to $200,256, annually. The actual base pay offered may vary 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 posted location(s).
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.
