Senior Quality Compliance Specialist - Integra LifeSciences
Boston, MA
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.
The Senior Quality Compliance Specialist has responsibility for supporting overall site Quality Management System (QMS) compliance. The Senior Specialist is a seasoned professional with complete and in-depth conceptual and practical knowledge of Quality Compliance and supports the site CAPA program, Quality Management Review preparation, Quality metrics, and the internal audit program. This position will support external audits in the capacity of backroom leadership and audit preparation. Works closely with all functional leaders to ensure on-going compliance and improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
+ Support the QMS processes and activities at the site.
+ Supports, and may lead, the development of new processes, standards, or plans in support of the organization's strategies.
+ Prioritizes the completion of activities and projects to meet business needs.
+ Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations / standards.
+ Support or lead Internal Audit Program, including conducting Internal Audits
+ Support of CAPA process, including coordination of CAPA Review Board (CRB).
+ This role requires experience in the back room of external audits, and preferably experience with FDA inspections.
+ Quality Management Review Coordination and preparation.
+ Quality Plan project management to ensure timely completion.
+ Support external audits including preparation and leadership/coordination of Backroom personnel and activities.
+ Leads or supports quality initiatives/projects as assigned.
+ Operates effectively with minimal supervision.
+ Other activities as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Bachelor's degree in Engineering, Life Science, or a related field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent education and years of experience
+ On-site position in Boston, MA with transition to a brand-new state of the art facility in Braintree, MA in 2025.
+ Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
+ Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
+ Experience as a Back room Lead during external audits (e.g., Notified Bodies and FDA).
+ Exceptional quality system and regulatory documentation writing and editing skills (e.g., CAPA records, audit NC responses).
+ Knowledge and direct experience with CAPA processes and records, including investigational techniques and CAPA boards.
+ Certified Quality Auditor is a plus.
+ Experience reviewing technical documentation.
+ Strong written and verbal communication skills
+ Strong critical thinking and analytical skills
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of position in order to successfully undertake 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, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds.
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.
The Senior Quality Compliance Specialist has responsibility for supporting overall site Quality Management System (QMS) compliance. The Senior Specialist is a seasoned professional with complete and in-depth conceptual and practical knowledge of Quality Compliance and supports the site CAPA program, Quality Management Review preparation, Quality metrics, and the internal audit program. This position will support external audits in the capacity of backroom leadership and audit preparation. Works closely with all functional leaders to ensure on-going compliance and improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
+ Support the QMS processes and activities at the site.
+ Supports, and may lead, the development of new processes, standards, or plans in support of the organization's strategies.
+ Prioritizes the completion of activities and projects to meet business needs.
+ Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations / standards.
+ Support or lead Internal Audit Program, including conducting Internal Audits
+ Support of CAPA process, including coordination of CAPA Review Board (CRB).
+ This role requires experience in the back room of external audits, and preferably experience with FDA inspections.
+ Quality Management Review Coordination and preparation.
+ Quality Plan project management to ensure timely completion.
+ Support external audits including preparation and leadership/coordination of Backroom personnel and activities.
+ Leads or supports quality initiatives/projects as assigned.
+ Operates effectively with minimal supervision.
+ Other activities as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Bachelor's degree in Engineering, Life Science, or a related field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent education and years of experience
+ On-site position in Boston, MA with transition to a brand-new state of the art facility in Braintree, MA in 2025.
+ Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
+ Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
+ Experience as a Back room Lead during external audits (e.g., Notified Bodies and FDA).
+ Exceptional quality system and regulatory documentation writing and editing skills (e.g., CAPA records, audit NC responses).
+ Knowledge and direct experience with CAPA processes and records, including investigational techniques and CAPA boards.
+ Certified Quality Auditor is a plus.
+ Experience reviewing technical documentation.
+ Strong written and verbal communication skills
+ Strong critical thinking and analytical skills
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of position in order to successfully undertake 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, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds.
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
