Senior Operations Quality Manager - Minneapolis, MN
4 weeks ago
Job summary
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 and compliance with all regulatory requirements.Your Role Responsible for functional team management including operations budgeting workforce planning Performance Management Employee Engagement Retention Succession Planning communicating job expectations planning coaching training and developing personal growth opportunities Participates in cross-functional teams as aQuality 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 ensure compliance to change requirements and approves change controls Drives quality investigations and reviews corrective action plans for adequacy and compliance This includes root cause analysis product impact assessments for investigations resulting from nonconformances Supports internal external audit programs assists in preparation of audit responses leads CAPA activityCAPA board reviews investigations ensures appropriate CAPA actions may own CAPA Manages calibration activities for instrumentation measurement test equipment resource optimization incoming material outgoing product acceptance activities resource optimization compliance with regulations Identifies facilitates leads continuous improvement efforts maintains Quality Metrics to support process improvement activities Responsible coordinating facilitating follow up on any Quality Leadership Team action items assigned Identifies communicates risks assists risk mitigation plans as necessary provides technical advice partners regulatory agency audits Youre The Right Fit If You have a minimum of years experience in FDA regulated medical device environments drugdevice combination products preferred focus on Operations Quality IQOQPQ processcontinuous improvement CAPA activities internal external audit programs receiving inspection sterilization calibration chemical analysis QMSprocessTesting standardization training etc You have a minimum of years experience in functional team management including budgeting workforce planning Performance Management Employee Engagement Retention Succession Planning coaching training etc You have strong understanding Medical Device regulationsstandards ISO13485/1497121CFR803806820 MDD EU MDR cGMP GDP Proven utilizing Quality KPIsData Analysis assess teamsite performance identify processcontinuous improvement opportunities Proven ability cultivate maintain strong relationships
- You must reside within commuting distance Plymouth MN.
Job description
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