Philips International
Senior Manager-Post Market Quality
Philips International, Colorado Springs, Colorado, United States, 80509
Senior Manager-Post Market Quality page is loaded## Senior Manager-Post Market Qualitylocations:
Colorado Springstime type:
Full timeposted on:
Posted Todayjob requisition id:
563919### Job TitleSenior Manager-Post Market Quality### Job DescriptionThe Senior Manager-Post Market Quality plays an important role within Philips Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment of quality issues for Recall/Correction & Removal decisions.**Your role:*** Establishes Post Market Quality operational objectives/work plans, delegates assignments to subordinates to ensure smooth execution/efficient distribution of tasks within the organization and fosters collaboration/productivity while aligning with overarching goals. Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.* Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.* Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.* Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.* Directs product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the device issue evaluations for decision and recall process (if applicable) to maintain compliance and uphold consumer safety.* Supports in external and internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality metrics, agreements, and records.* Formulates/implements the Business’ long-range quality, regulatory and compliance policy and creates Q&R awareness level as determined within the organization.* Enforces (a simplified) quality system and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting with action for negative trends.* **Manages:** compliance with FDA regulations/Regulatory Agencies guidelines and policies, the review and approval of finished products in accordance with approved specifications (includes Complaint handling) and product recall activities to include recall policies and procedures for the company.**You're the right fit if:*** You’ve acquired a minimum of 10+ years’ experience in Post Market Quality within FDA regulated medical device/product environments, with proven experience in Quality Planning, Complaint Handling, returns, investigations, Corrections & Removals, Recalls, QMS simplification/harmonization, CAPA’s, Internal/External Audit-compliance to FDA regulations/Regulatory Agencies guidelines and policies.* You have a minimum of 3+ years’ experience managing Post Market Quality teams, including employee selection, performance management, compensation management, career development, effective operational management and fostering a culture of continuous improvement/quality excellence in customer relations within the team.* You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.* You’ve acquired a minimum of a Bachelor’s Degree (required) in Engineering, Quality or related disciplines. Master’s degree desired.* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this **.****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 .* Discover* Learn more about* Learn more about**Philips Transparency Details:*** The pay range for this position in Colorado Springs, CO is $114,750 to $183,600.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.***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.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 .**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 Colorado Springs, CO.***#LI-PH1***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 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, #J-18808-Ljbffr
Colorado Springstime type:
Full timeposted on:
Posted Todayjob requisition id:
563919### Job TitleSenior Manager-Post Market Quality### Job DescriptionThe Senior Manager-Post Market Quality plays an important role within Philips Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment of quality issues for Recall/Correction & Removal decisions.**Your role:*** Establishes Post Market Quality operational objectives/work plans, delegates assignments to subordinates to ensure smooth execution/efficient distribution of tasks within the organization and fosters collaboration/productivity while aligning with overarching goals. Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.* Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.* Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.* Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.* Directs product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the device issue evaluations for decision and recall process (if applicable) to maintain compliance and uphold consumer safety.* Supports in external and internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality metrics, agreements, and records.* Formulates/implements the Business’ long-range quality, regulatory and compliance policy and creates Q&R awareness level as determined within the organization.* Enforces (a simplified) quality system and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting with action for negative trends.* **Manages:** compliance with FDA regulations/Regulatory Agencies guidelines and policies, the review and approval of finished products in accordance with approved specifications (includes Complaint handling) and product recall activities to include recall policies and procedures for the company.**You're the right fit if:*** You’ve acquired a minimum of 10+ years’ experience in Post Market Quality within FDA regulated medical device/product environments, with proven experience in Quality Planning, Complaint Handling, returns, investigations, Corrections & Removals, Recalls, QMS simplification/harmonization, CAPA’s, Internal/External Audit-compliance to FDA regulations/Regulatory Agencies guidelines and policies.* You have a minimum of 3+ years’ experience managing Post Market Quality teams, including employee selection, performance management, compensation management, career development, effective operational management and fostering a culture of continuous improvement/quality excellence in customer relations within the team.* You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.* You’ve acquired a minimum of a Bachelor’s Degree (required) in Engineering, Quality or related disciplines. Master’s degree desired.* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this **.****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 .* Discover* Learn more about* Learn more about**Philips Transparency Details:*** The pay range for this position in Colorado Springs, CO is $114,750 to $183,600.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.***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.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 .**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 Colorado Springs, CO.***#LI-PH1***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 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, #J-18808-Ljbffr