Manager, Quality Compliance - Integra LifeSciences
Cincinnati, OH
About the Job
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.
Summary Description
The Manager, Quality Compliance will have a key leadership role ensuring overall site QMS compliance. Additionally, they will manage QMS systems, processes and personnel, including at a minimum, Document Control, Internal Audits, CAPA, Change Controls and training. Will serve as alternate Quality Management Representative for the site with responsibilities including Quality Management Review preparation, Audit/inspection Backroom leadership and site Quality Leadership Team coordination. Works closely with all functional leaders to ensure on-going compliance and improvement.
Supervision Received
Under direct supervision of Director, Quality Assurance
Supervision Exercised
Audit Team
Document Control/Quality Records Personnel
QA Analyst
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.
+ Management of Document Control/Quality Records processes and personnel.
+ Management of Internal Audit Program and Audit Team.
+ Management of central CAPA process, including coordination of CAPA Review Board (CRB).
+ Management of site Training Program to ensure compliance.
+ Quality Management Review coordination and preparation.
+ Quality Plan project management to ensure timely completion.
+ Alternate site Quality Management Representative in absence of QA Director.
+ Backroom Leader during site audit/inspections. Alternate Front Room Leader.
+ Other QA/Compliance activities as assigned by Director of QA Operations
Desired Minimum Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
Bachelor's degree in quality assurance or related discipline with 3+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience in QA/Compliance within Medical Device Industry. OR Master degree in Quality Assurance or related discipline with 0-2 years of experience leading a team or equivalent education and years of management experience in QA/Compliance within Medical Device Industry.
+ Extensive experience with development and implementation of quality management systems.
+ Expert knowledge of medical device regulations (including FDA QSRs. ISO13485).
+ Experience with developing or improving Document Control and Records Control processes.
+ Experience with Training Program development/implementation.
+ Experience conducting QMS/Quality training.
+ Audit experience and certified Auditor.
+ Experience in personnel management and mentoring.
+ Demonstrated experience in successfully leading a team.
+ Experience in project management.
+ Ability to interface with top organizational leadership in an effective manner.
+ Ability to communicate effectively (both written and verbal).
+ Ability to influence positive change across the organization
+ Exceptional conflict resolution skills.
Tools and Equipment Used
Ability to utilize a computer, and familiarity with Microsoft Office. Knowledge of systems such as Oracle, Agile and Trackwise would be a benefit.
Physical Requirements
The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required for the position in order to successfully the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
Adverse Working Conditions
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, high precarious places, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
There are no adverse working conditions associated with this position.
Selection Guidelines
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
Disclaimer
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by employer as the needs of the employer and requirements of the job change.
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.
Summary Description
The Manager, Quality Compliance will have a key leadership role ensuring overall site QMS compliance. Additionally, they will manage QMS systems, processes and personnel, including at a minimum, Document Control, Internal Audits, CAPA, Change Controls and training. Will serve as alternate Quality Management Representative for the site with responsibilities including Quality Management Review preparation, Audit/inspection Backroom leadership and site Quality Leadership Team coordination. Works closely with all functional leaders to ensure on-going compliance and improvement.
Supervision Received
Under direct supervision of Director, Quality Assurance
Supervision Exercised
Audit Team
Document Control/Quality Records Personnel
QA Analyst
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.
+ Management of Document Control/Quality Records processes and personnel.
+ Management of Internal Audit Program and Audit Team.
+ Management of central CAPA process, including coordination of CAPA Review Board (CRB).
+ Management of site Training Program to ensure compliance.
+ Quality Management Review coordination and preparation.
+ Quality Plan project management to ensure timely completion.
+ Alternate site Quality Management Representative in absence of QA Director.
+ Backroom Leader during site audit/inspections. Alternate Front Room Leader.
+ Other QA/Compliance activities as assigned by Director of QA Operations
Desired Minimum Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
Bachelor's degree in quality assurance or related discipline with 3+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience in QA/Compliance within Medical Device Industry. OR Master degree in Quality Assurance or related discipline with 0-2 years of experience leading a team or equivalent education and years of management experience in QA/Compliance within Medical Device Industry.
+ Extensive experience with development and implementation of quality management systems.
+ Expert knowledge of medical device regulations (including FDA QSRs. ISO13485).
+ Experience with developing or improving Document Control and Records Control processes.
+ Experience with Training Program development/implementation.
+ Experience conducting QMS/Quality training.
+ Audit experience and certified Auditor.
+ Experience in personnel management and mentoring.
+ Demonstrated experience in successfully leading a team.
+ Experience in project management.
+ Ability to interface with top organizational leadership in an effective manner.
+ Ability to communicate effectively (both written and verbal).
+ Ability to influence positive change across the organization
+ Exceptional conflict resolution skills.
Tools and Equipment Used
Ability to utilize a computer, and familiarity with Microsoft Office. Knowledge of systems such as Oracle, Agile and Trackwise would be a benefit.
Physical Requirements
The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required for the position in order to successfully the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
Adverse Working Conditions
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, high precarious places, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
There are no adverse working conditions associated with this position.
Selection Guidelines
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
Disclaimer
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by employer as the needs of the employer and requirements of the job change.
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)
Source : Integra LifeSciences