Quality Control Inspection Supervisor

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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 Quality Control Inspector Supervisor will be overseeing the quality control inspection activities to ensure the safety, efficacy, and quality of the company’s medical devices. This role is expected to provide technical and supervisory leadership and mentoring to the quality control inspectors and provides support to management. This job is expected to work onsite. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Oversee all activities related to quality control inspection, including product inspection, incoming material inspection, and management of quarantined materials.
• Perform scheduling and delegation of duties for the quality control inspection team.
• Coordinates production activities with Operations teams and schedules QC personnel to support these activities across weekend shifts.
• Communicate with operations to ensure the priorities needed for production are covered.
• Responsible for reviewing and approving QC results, including incoming and in-process inspections.
• Reports any non-conformances in a timely manner.
• Author and/or support non-conformance and CAPA investigations as required.
• Author or revise Standard Operating Procedures (SOPs).
• Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits.
• Interpret and work within the guidelines of drawings, specifications, charts, procedures, and other data to determine product or material acceptance.
• Maintain GMP documentation and adhere to Good Documentation Practices.
• Read and interpret sampling plan as per the American National Standard Institute (ANSI).
• Oversees physical and electronic quarantine locations.
• Provides staff with leadership, support, and mentoring. Conducts performance reviews for lab personnel, holds regular team meetings, and provides training to junior staff as needed.
• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor’s degree or higher in Science, Engineering, or related fields is desired.
• 7+ years of relevant GMP/GLP laboratory experience in regulated industry, with supervisory and/or project leadership experience.
• Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings.
• Knowledge of MS Office Suite
• Knowledge of Oracle R12 and/or Agile PLM preferred.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this 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 speak and write in English. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to periodically lift and/or move up to 25lbs. The employee requires visual acuity and color perception adequate to perform job duties. Eyesight correctable to 20/25 to detect the presence of defined defect classifications in/on product/materials.

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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EEO Is the Law | EOE including Disability/Protected Veterans

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 . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].