Sr. Quality Manager - Sterility Assurance
Recruiter:
Spencer Gregory Hale Sr.
Quality Manager - Sterility Assurance About This Role:
The Quality Manager II will oversee ongoing sterility assurance sustaining activities across Boston Scientific.
This role will be responsible for a team of scientists and technicians based out of multiple sites.
Provides technical support to Global Sterilization Operations to ensure compliance to policies and standards relating to Sterilization and Sterility Assurance.
Develops and maintains processes to ensure the ongoing qualification of sterile product.
Your Responsibilities Will Include:
Manages Sterilization Scientists and Engineers to ensure compliance to regulations, standards and corporate policies related to Sterility Assurance.
Reviews and approves a wide variety of validation procedures, assessments, investigations and reports.
Drives qualification and requalification projects of major magnitude and scope.
Develops and monitors the group strategies, objectives, and budget.
Provides technical oversight for process and test improvement and development.
Drives and evaluates project and group progress and results.
Hires qualified personnel and promotes their retention and career development.
Manages, coaches and develops staff consisting of Microbiologists, Scientists, and Technicians.
Gives opinions and interpretations to internal customers related to Sterilization qualification results and conclusions.
Reviews and provides input to Regulatory submissions and questions in regards to sterilization process qualifications.
Assists with investigations related to Sterility Assurance.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Responsible for preparing for audits and inspections and representing Boston Scientific as a Sterility Assurance Subject Matter Expert.
Drives and oversees projects for continuous improvement in Sterility Assurance practices.
Lead a team of employees in the achievement of organizational goals.
Guide, coach, direct, and develop direct reports, and drive best practices throughout the organization.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
May direct and control the activities and budget of one or more functional areas.
Monitor and ensure compliance with company policies and procedures (e.
g.
federal/country and regulatory requirements).
What We're Looking For In You:
Minimum
Qualifications:
BS Microbiology, Engineering or related scientific discipline Experience in managing multiple projects across multiple organizational disciplines Strong technical knowledge of Ethylene Oxide Sterilization processes and equipment Strong verbal, written communication skills, both technical and conversational 7
years of related experience, including 2
years of leadership experience and 5
years Quality Assurance experience Preferred
Qualifications:
Experience leading technical teams 5
years working in the medical device industry or other similarly regulated industry Requisition ID:
567150 Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions.
This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a requirement.
The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Recommended Skills Assessments Auditing Business Process Improvement Coaching And Mentoring Communication Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Spencer Gregory Hale Sr.
Quality Manager - Sterility Assurance About This Role:
The Quality Manager II will oversee ongoing sterility assurance sustaining activities across Boston Scientific.
This role will be responsible for a team of scientists and technicians based out of multiple sites.
Provides technical support to Global Sterilization Operations to ensure compliance to policies and standards relating to Sterilization and Sterility Assurance.
Develops and maintains processes to ensure the ongoing qualification of sterile product.
Your Responsibilities Will Include:
Manages Sterilization Scientists and Engineers to ensure compliance to regulations, standards and corporate policies related to Sterility Assurance.
Reviews and approves a wide variety of validation procedures, assessments, investigations and reports.
Drives qualification and requalification projects of major magnitude and scope.
Develops and monitors the group strategies, objectives, and budget.
Provides technical oversight for process and test improvement and development.
Drives and evaluates project and group progress and results.
Hires qualified personnel and promotes their retention and career development.
Manages, coaches and develops staff consisting of Microbiologists, Scientists, and Technicians.
Gives opinions and interpretations to internal customers related to Sterilization qualification results and conclusions.
Reviews and provides input to Regulatory submissions and questions in regards to sterilization process qualifications.
Assists with investigations related to Sterility Assurance.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Responsible for preparing for audits and inspections and representing Boston Scientific as a Sterility Assurance Subject Matter Expert.
Drives and oversees projects for continuous improvement in Sterility Assurance practices.
Lead a team of employees in the achievement of organizational goals.
Guide, coach, direct, and develop direct reports, and drive best practices throughout the organization.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
May direct and control the activities and budget of one or more functional areas.
Monitor and ensure compliance with company policies and procedures (e.
g.
federal/country and regulatory requirements).
What We're Looking For In You:
Minimum
Qualifications:
BS Microbiology, Engineering or related scientific discipline Experience in managing multiple projects across multiple organizational disciplines Strong technical knowledge of Ethylene Oxide Sterilization processes and equipment Strong verbal, written communication skills, both technical and conversational 7
years of related experience, including 2
years of leadership experience and 5
years Quality Assurance experience Preferred
Qualifications:
Experience leading technical teams 5
years working in the medical device industry or other similarly regulated industry Requisition ID:
567150 Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions.
This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a requirement.
The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Recommended Skills Assessments Auditing Business Process Improvement Coaching And Mentoring Communication Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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