Integra LifeSciences
Quality Manager
Integra LifeSciences, Irvine, California, United States, 92713
Changing lives. Building Careers.
Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
This position is accountable and responsible for the strategic leadership, management and direction of the Irvine Quality functions by developing a best-in-class quality team. The incumbent will ensure the organizational talent and resources are aligned with key business imperatives and delivers results with a commitment to excellence. Develop short and long-term programs to maximize product quality, improve demand planning and continuously support a maximum performance level. This leader shall demonstrate business quality acumen and sound decision making, apply systematic methodologies, resolve quality issues and manage a team across a matrix organization. Create a culture of high performance and hold self and others accountable. This position will act as the Management Representative for Irvine (Rebound Therapeutics) site. This Quality Leader will create an environment in which creativity and innovation are the norm and change is not only accepted but encouraged by championing innovation and change.
RESPONSIBILITIES:
Provide leadership (specifically as the management representative and the person responsible for regulatory compliance) and ensure the operational success of quality functions with an emphasis on product quality, prevention, continuous improvement and customer satisfaction.
Continuously evaluate effectiveness of quality functions to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management. Implement metrics and KPls that demonstrate the effectiveness, timeliness and the accuracy of the Quality functions, in addition to standard quality business performance metrics (i.e. Productivity, Efficiency, Capacityutilization rate, First Pass Quality Resource Utilization %)
Ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations.
Responsible for the collection and reporting of metrics and data to divisions, facility and department management per defined schedules or ad hoc when required to communicate involvement and results of quality engineering activities.
Responsible for reviewing data and metrics and taking or proposing appropriate action, as required. Develops creative solutions to problems as they arise.
DESIRED MINIMUM QUALIFICATIONS:
Bachelor's degree with 5+ years of experience leading a team, master's degree with 3+ years of experience leading a team, Doctoral degree with 3+ years of experience leading a team.
Bachelor's degree is required in an Engineering discipline, Quality Assurance, or Biological Science.
Minimum of eight (8) years' experience in a regulated environment, preferably Medical Device.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as cGMP, MDSAP (including FDA regulations such as 21CFR820), ISO series of quality standards such as ISO 13485, and European Union Medical Device Law such as MDD/MDR.
Demonstrated ability to:
build high levels of engagement throughout a plant environment.
build a superior leadership team and bench.
develop and maintain key internal and external professional relationships.
generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency.
quickly gain the respect and support of own staff and fellow leaders.
build customer relationships with lntegra LlfeSclences' partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
Exemplifies Leadership Integrity and Courage
Ability to travel up to 10% of the Time
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
This position is accountable and responsible for the strategic leadership, management and direction of the Irvine Quality functions by developing a best-in-class quality team. The incumbent will ensure the organizational talent and resources are aligned with key business imperatives and delivers results with a commitment to excellence. Develop short and long-term programs to maximize product quality, improve demand planning and continuously support a maximum performance level. This leader shall demonstrate business quality acumen and sound decision making, apply systematic methodologies, resolve quality issues and manage a team across a matrix organization. Create a culture of high performance and hold self and others accountable. This position will act as the Management Representative for Irvine (Rebound Therapeutics) site. This Quality Leader will create an environment in which creativity and innovation are the norm and change is not only accepted but encouraged by championing innovation and change.
RESPONSIBILITIES:
Provide leadership (specifically as the management representative and the person responsible for regulatory compliance) and ensure the operational success of quality functions with an emphasis on product quality, prevention, continuous improvement and customer satisfaction.
Continuously evaluate effectiveness of quality functions to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management. Implement metrics and KPls that demonstrate the effectiveness, timeliness and the accuracy of the Quality functions, in addition to standard quality business performance metrics (i.e. Productivity, Efficiency, Capacityutilization rate, First Pass Quality Resource Utilization %)
Ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations.
Responsible for the collection and reporting of metrics and data to divisions, facility and department management per defined schedules or ad hoc when required to communicate involvement and results of quality engineering activities.
Responsible for reviewing data and metrics and taking or proposing appropriate action, as required. Develops creative solutions to problems as they arise.
DESIRED MINIMUM QUALIFICATIONS:
Bachelor's degree with 5+ years of experience leading a team, master's degree with 3+ years of experience leading a team, Doctoral degree with 3+ years of experience leading a team.
Bachelor's degree is required in an Engineering discipline, Quality Assurance, or Biological Science.
Minimum of eight (8) years' experience in a regulated environment, preferably Medical Device.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as cGMP, MDSAP (including FDA regulations such as 21CFR820), ISO series of quality standards such as ISO 13485, and European Union Medical Device Law such as MDD/MDR.
Demonstrated ability to:
build high levels of engagement throughout a plant environment.
build a superior leadership team and bench.
develop and maintain key internal and external professional relationships.
generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency.
quickly gain the respect and support of own staff and fellow leaders.
build customer relationships with lntegra LlfeSclences' partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
Exemplifies Leadership Integrity and Courage
Ability to travel up to 10% of the Time
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)