Senior Manager, Quality Control

As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

**Purpose of this role**:
The Senior Manager, Quality Control requires highly collaborative work with various cross-functions such as Global Sourcing, Global Planning, R&D and Manufacturing Operations. Additionally, he/she is responsible for directly working to resolve quality problems and close process gaps and implement corrective actions where applicable; and maintain accurate quality records in compliance with the SCIEX Quality System.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Responsible for overseeing the day-to-day operations of the Quality Control team, work with multiple stakeholders and functional leaders to develop the overall strategy for quality control monitoring, to support operational excellence.
Manage a team of technicians and specialists, and responsible for building and developing a high-performing Quality Control team, including setting team and individual goals and assessing performance and being able to advise and support team growth.
Responsible for implementing, maintaining, and improving the SCIEX Quality Systems in accordance with ISO 9001, ISO 13485 and US 21 CFR 820 throughout the day-to-day activities.
Responsible for establishing, implementing, reviewing and revising applicable procedures to close process gaps.
Responsible for supporting investigation of the NCMR materials/parts and quality related issues to determine root cause and identify/implement corrective actions to prevent recurrence, raise NCMR, ensuring relevant stakeholders, process owners are engaged and escalating when necessary.
Responsible for leading and/or participating in continuous improvement projects and events, such as Kaizen workshops, etc to improve SCIEX quality and capability.
Ensure quality and accuracy of integrated project plans encompassing all cross-functional stakeholders for decision-making, to avoid escape of potential risk.
Ensure inspection activities are in compliance includes 3-Party Logistics, with closely with Supplier Quality team to improve the reaction mechanisms and NCMR is adopted and adhered, includes provide necessary training to inspectors at 3-PL to ensure the adherence to Sciex quality processes.
Support Senior Leadership team by sponsoring innovative ideas to improve Quality operation, by recommending, supporting, and implementing continuous improvement activities in processes, to optimize results to improve quality of delivery, meeting quality standards requirements deliverable in according with Company and Customer requirements.
Serves as the process Subject Matter Expert (SME) during internal and external audits (Quality System Registrars, Regulatory agencies, customers, etc.).
Support activities relating to Field Action when needed. Collaborating and gathering data to identify and interprete performance trends/metrics, analyzes, summarizes, and communicates pertinent information to management. Ensure timely, accurate and complete data reporting.
Implement benchmark and best-practice activities in all areas of responsibilities to maintain exceptionally high levels of quality and compliance across the Danaher OpCos.
Collaborates with other OpCos across Danaher, across functions, and ensure maintaining healthy working partnership with all levels.
Utilizes Danaher Business Systems (DBS) tools to drive compliant and effective processes; improves capability to support market growth.

Why you?

**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in engineering
Minimum 5-8 years experience in Quality-related functions with a focus on manufacturing quality or design quality or equivalent.
Minimum 3-5 years experience in people management, including ability to manage remote teams; leading projects or equivalent.
Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, ISO 13485, ISO 9001
Knowledge of quality system management principles and regulatory requirements for medical devices with the ability to train and coach all levels of staff.

**Preferred Qualif