Senior Manager, Quality Control
Changing lives.
Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.
Thinking differently is what we do best.
To us, change equals opportunity.
Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Senior Manager, Quality Control leads, coordinates and evaluates the activities of employees in Quality Control and Quality Inspection.
Activities include the development of quality programs and policies that ensure the compliant manufacturing and distribution of medical devices.
Directly supervises employees in the Quality Inspection, Micro Lab, and Quality Control.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Builds high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation and execution of CAPAs, continuous improvement initiatives, and other quality initiatives.
Provides strategic direction and communication of the company's goals, directives and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company's goals and increased profitability.
Ensure dependable and timely results from quality control, including process control and support for process changes in compliance with QSR, ISO and other regulatory requirements.
Ensure and improve product reliability through proven quality science.
Post market surveillance, CAPA, Complaints, reduction of nonconformity.
Oversee product quality reviews, divisional management reviews and preparation of quality reports as applicable for various forums, Divisional Board Review (DBR), Plant Operational reviews etc.
Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR and JPAL.
Ensures site compliance and readiness.
Oversees external regulatory inspections, timely follow up and closure of Regulatory commitments.
Interact and coordinate activities with other departments, external vendors and customers.
Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
Ensure that all projects and validations are in compliance with QSR, ISO and other regulatory requirements.
Participate in evaluation of new product opportunities (introductions, enhancements, obsolescence).
Maintain fiscal responsibility and budget compliance.
Education and
Experience:
Bachelor degree or equivalent with 8
years of experience leading a team, Master degree with 5
years of experience leading a team, Doctoral degree with 3
years of experience leading a team Minimum of 5 years' experience supervising a laboratory in a regulated industry, preferably Medical Device Industry.
Expert knowledge and application of GLPs.
Working knowledge of medical device regulations (including FDA QSRs, 15013485).
High level of technical aptitude Excellent mathematical skills (sampling plans).
Ability to use a wide assortment of QC inspection, measuring and test equipment as well as laboratory techniques to ensure product is manufactured and functioning according to specification.
Ability to read and interpret technical documentation and references.
Ability to comprehend and execute procedures.
Experience with CAPA processes (e.
g.
, nonconforming product, product holds investigational techniques,).
Demonstrated experience in successfully leading a team.
Experience in project management.
Ability to effectively communicate to all levels of management within the organization.
Demonstrated ability to work cross-functionally in a team environment.
Ability to communicate effectively (both written and oral) using English (or local language).
Exceptional conflict-resolution skills.
Familiar with the MS Office Suite, including Microsoft Visio.
Familiar with ERP systems, Oracle preferred.
Quality certification preferred Recommended Skills Business Process Improvement English Enterprise Resource Planning Iso 13485 Leadership Manufacturing Estimated Salary: $20 to $28 per hour based on qualifications.
Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.
Thinking differently is what we do best.
To us, change equals opportunity.
Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Senior Manager, Quality Control leads, coordinates and evaluates the activities of employees in Quality Control and Quality Inspection.
Activities include the development of quality programs and policies that ensure the compliant manufacturing and distribution of medical devices.
Directly supervises employees in the Quality Inspection, Micro Lab, and Quality Control.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Builds high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation and execution of CAPAs, continuous improvement initiatives, and other quality initiatives.
Provides strategic direction and communication of the company's goals, directives and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company's goals and increased profitability.
Ensure dependable and timely results from quality control, including process control and support for process changes in compliance with QSR, ISO and other regulatory requirements.
Ensure and improve product reliability through proven quality science.
Post market surveillance, CAPA, Complaints, reduction of nonconformity.
Oversee product quality reviews, divisional management reviews and preparation of quality reports as applicable for various forums, Divisional Board Review (DBR), Plant Operational reviews etc.
Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR and JPAL.
Ensures site compliance and readiness.
Oversees external regulatory inspections, timely follow up and closure of Regulatory commitments.
Interact and coordinate activities with other departments, external vendors and customers.
Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
Ensure that all projects and validations are in compliance with QSR, ISO and other regulatory requirements.
Participate in evaluation of new product opportunities (introductions, enhancements, obsolescence).
Maintain fiscal responsibility and budget compliance.
Education and
Experience:
Bachelor degree or equivalent with 8
years of experience leading a team, Master degree with 5
years of experience leading a team, Doctoral degree with 3
years of experience leading a team Minimum of 5 years' experience supervising a laboratory in a regulated industry, preferably Medical Device Industry.
Expert knowledge and application of GLPs.
Working knowledge of medical device regulations (including FDA QSRs, 15013485).
High level of technical aptitude Excellent mathematical skills (sampling plans).
Ability to use a wide assortment of QC inspection, measuring and test equipment as well as laboratory techniques to ensure product is manufactured and functioning according to specification.
Ability to read and interpret technical documentation and references.
Ability to comprehend and execute procedures.
Experience with CAPA processes (e.
g.
, nonconforming product, product holds investigational techniques,).
Demonstrated experience in successfully leading a team.
Experience in project management.
Ability to effectively communicate to all levels of management within the organization.
Demonstrated ability to work cross-functionally in a team environment.
Ability to communicate effectively (both written and oral) using English (or local language).
Exceptional conflict-resolution skills.
Familiar with the MS Office Suite, including Microsoft Visio.
Familiar with ERP systems, Oracle preferred.
Quality certification preferred Recommended Skills Business Process Improvement English Enterprise Resource Planning Iso 13485 Leadership Manufacturing Estimated Salary: $20 to $28 per hour based on qualifications.
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