Senior Operations Quality Manager

Koninklijke Philips N.V•Plymouth, MA

12d•Onsite

About The Position

The Senior Operations Quality Manager will manage the Quality Operations team and be the Site leader for our Plymouth, MN Image Guided Therapy Devices (IGTD) site, ensuring alignment with corporate goals andpliance with all regulatory requirements. Your role: Responsible for functional team management including operations, budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning,municating job expectations, planning, coaching, training, and developing personal growth opportunities. Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Philips or at contracted suppliers. Assists Change Control owners to assess impact of change, ensurepliance to change requirements, and approves change controls. Drives quality investigations and reviews corrective action plans for adequacy andpliance. This includes root cause analysis and product impact assessments for investigations resulting from nonconformances. Supports internal /external audit programs, assists in preparation of audit responses and leads CAPA activity-CAPA board, reviews investigations, ensures appropriate CAPA actions, may own CAPA. Manages- calibration activities for instrumentation, measurement and test equipment, resource optimization, and iing material and outgoing product acceptance activities, resource optimization, andpliance with regulations. Identifies, facilitates, and/or leads continuous improvement efforts and maintains Quality Metrics to support process improvement activities. Responsible for coordinating, facilitating and follow up on any Quality Leadership Team action items assigned. Identifies andmunicates risks and assists with risk mitigation plans as necessary and provides technical advice for partners and regulatory agency audits.

Requirements

You have a minimum of 10+ years' experience in FDA regulated medical device environments (drug-devicebination products preferred), with a focus on Operations Quality (IQ/OQ/PQ), process/continuous improvement, CAPA activities, internal /external audit programs, receiving inspection, sterilization, calibration, chemical analysis, QMS/process/Testing standardization, training etc.
You have a minimum of 3+ years' experience in functional team management 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, cGMP, and GDP.
You have proven experience utilizing Quality KPI's/Data Analysis to assess team/site performance and identify process/continuous improvement opportunities.
You have the proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders.
You have a minimum of a Bachelor's degree in Quality, Engineering or a related Scientific discipline (required).

Nice To Haves

ASQ certifications (desired).

Responsibilities

Functional team management including operations, budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning,municating job expectations, planning, coaching, training, and developing personal growth opportunities.
Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Philips or at contracted suppliers.
Assists Change Control owners to assess impact of change, ensurepliance to change requirements, and approves change controls.
Drives quality investigations and reviews corrective action plans for adequacy andpliance. This includes root cause analysis and product impact assessments for investigations resulting from nonconformances.
Supports internal /external audit programs, assists in preparation of audit responses and leads CAPA activity-CAPA board, reviews investigations, ensures appropriate CAPA actions, may own CAPA.
Manages- calibration activities for instrumentation, measurement and test equipment, resource optimization, and iing material and outgoing product acceptance activities, resource optimization, andpliance with regulations.
Identifies, facilitates, and/or leads continuous improvement efforts and maintains Quality Metrics to support process improvement activities.
Responsible for coordinating, facilitating and follow up on any Quality Leadership Team action items assigned.
Identifies andmunicates risks and assists with risk mitigation plans as necessary and provides technical advice for partners and regulatory agency audits.