Sr. Director, Product Quality
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 Sr.
Director, Product Quality directly supervises employees in the Quality Assurance, Quality Engineering and Quality Control departments for the Boston Manufacturing site.
These activities include the development, implementation, and monitoring of quality programs and policies that ensure the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.
S.
Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Directly supervises employees in the Quality Department.
Fulfills 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, collaborative environment resulting in the achievement of the company's goals and increased profitability.
Oversees manufacturing quality and drives standardization & consistency between the site and corporate QMS.
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.
Lead in the front room for all regulatory inspections.
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.
Perform other related duties as expected.
DESIRED MINIMUM QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
High educational background/Master in a scientific discipline required with a minimum of 15 years of experience in the medical device or pharmaceutical industry and minimum 7 years of people management experience.
Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
Significant area of expertise developed through experience and positive track record.
Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
Experience with direct contact with FDA and EU Notified Bodies.
Knowledge of process design and implementation, change control, auditing, and document management systems.
General knowledge of statistical analysis.
Demonstrated organizational, management and communication skills.
Must be able to read and write in English.
Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Ability to travel up to 10% or more if needed based on site needs.
Recommended Skills Analytical Auditing Business Process Improvement Change Control Communication Corrective And Preventive Action (Capa) 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 Sr.
Director, Product Quality directly supervises employees in the Quality Assurance, Quality Engineering and Quality Control departments for the Boston Manufacturing site.
These activities include the development, implementation, and monitoring of quality programs and policies that ensure the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.
S.
Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Directly supervises employees in the Quality Department.
Fulfills 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, collaborative environment resulting in the achievement of the company's goals and increased profitability.
Oversees manufacturing quality and drives standardization & consistency between the site and corporate QMS.
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.
Lead in the front room for all regulatory inspections.
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.
Perform other related duties as expected.
DESIRED MINIMUM QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
High educational background/Master in a scientific discipline required with a minimum of 15 years of experience in the medical device or pharmaceutical industry and minimum 7 years of people management experience.
Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
Significant area of expertise developed through experience and positive track record.
Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
Experience with direct contact with FDA and EU Notified Bodies.
Knowledge of process design and implementation, change control, auditing, and document management systems.
General knowledge of statistical analysis.
Demonstrated organizational, management and communication skills.
Must be able to read and write in English.
Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Ability to travel up to 10% or more if needed based on site needs.
Recommended Skills Analytical Auditing Business Process Improvement Change Control Communication Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
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