Quality Compliance Manager

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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 whats 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 ongoing 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:

Bachelors 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 02 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.

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