Senior Quality Operations Manager-Ultrasound

Philips Lighting Co.; Pennsylvania; On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

PTO

401k

Stock plan

Education reimbursement

Job summary

Philips in Reedsville, PA seeks a Senior Quality Operations Manager for Ultrasound transducer manufacturing. You will oversee CAPA, NCs, and QN management, ensure PFMEA alignment with design changes, and lead validation and product transfer activities to uphold quality standards.

Further responsibilities include driving supplier quality improvements, cross-functional collaboration with R&D, manufacturing and regulatory teams, and guiding a team of quality professionals to ensure compliant

Qualifications

• 7+ years’ experience in FDA regulated medical device manufacturing environments, with a focus on Operations/Process Quality (IQ/OQ/PQ), investigating/ supervising nonconformance events, CAPA activities, internal /external audit programs and process validation and continuous improvement.

Responsibilities

• Manage the CAPA process, investigate nonconformances, determine root causes, and implement corrective actions; monitor CAPA effectiveness and NC/QN management.
• Plan PFMEA impact assessments related to design changes and support Manufacturing Process Development and Design Transfer.
• Oversee testing robustness of product transfer validations in the factory and ensure NPIs and transfers meet quality norms.
• Drive supplier quality initiatives and collaborate with R&D, manufacturing and regulatory affairs to close process gaps.

Skills

CAPA management

QA leadership

Regulatory knowledge

Audit programs

Education

Bachelor's degree in Quality, Engineering or related Scientific discipline

Job description

Job Title

Senior Quality Operations Manager-Ultrasound

Job Description

The Senior Quality Operations Manager will be responsible for Quality team management, oversight of quality operations, driving critical quality/continuous improvement initiatives and ensuring site compliance for our Reedsville Ultrasound Transducer manufacturing site.

Your role:

• Manages the Corrective and Preventive Actions (CAPA) process rigorously, investigating nonconformances, determining root causes, and implementing robust corrective and preventive actions, while monitoring CAPA effectiveness and overseeing the management of Non-Conformances (NC) and Quality Notifications (QN).
• Plans the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Provides oversight for testing robustness of product transfer validations in the factory, report on project status of new products or transfers to factory and ensures validation activities and employee capabilities to support validation of process controls and completeness of New Product Introduction (NPI) or product transfers into factory to quality norms.
• Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and uphold superior quality benchmarks.
• Possesses complete knowledge of products/services, often leads a cooperative effort among project team members, and frequently interacts with subordinates, supervisors, customers, and functional peer groups on matters between functional areas.
• Drives resolution of quality non-conformities with Philips internal suppliers and drives process validation as local factory-level QMS process owner to ensure adherence to quality standards and regulatory requirements.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Leads critical quality engineering and assurance tasks, ensuring the maintenance of manufacturing quality systems, ensuring risk management, and driving significant process improvement initiatives to facilitate New Product Introduction (NPI) completion and product transfers.
• Manages issues necessitating an in-depth understanding of organizational objectives through the analysis of situations or data and implements strategic policies when determining methods, techniques, and evaluation criteria to achieve desired outcomes.

You're the right fit if:

• You have a minimum of 7+ years’ experience in FDA regulated medical device manufacturing environments, with a focus on Operations/Process Quality (IQ/OQ/PQ), investigating/ supervising nonconformance events, CAPA activities, internal /external audit programs and process validation and continuous improvement.
• You have proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have proven experience utilizing Quality KPI’s/Data Analysis to assess project/team performance and identify process and continuous improvement opportunities.
• You’re able to effectively communicate, influence and build relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and able to manage/facilitate audits and inspections with the FDA, competent authorities, Regulatory Agencies and Notified Body.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required). ASQ certifications (desired).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. 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 of 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 Reedsville, PA is $120,000 to $190,000

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 here.

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 Reedsville, PA.
• This role may require travel up to 10%.

#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.

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