Quality Supervisor

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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUPERVISION RECEIVED

Under direct supervision the Manager of Quality Engineering

SUPERVISION EXERCISED

Quality Control Inspectors

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Primary responsibilities are to:

• Supervises the quality control team to build maintain and cross train an effective workforce.
• Prioritizes the completion of quality inspection tasks to meet production deadlines & supply chain commitments.
• Assist with Control of Nonconforming Product process activities (e.g. product quarantine.
• Support Measurement/Test Methods Validations as needed.
• Supports internal and external audit/inspection activities.
• Supports batch record review and product releases.

Note: Other duties may be assigned as necessary.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge skill and/or ability required for this position.

Education and Experience

• BS degree in Engineering Math or Science (Biology Chemistry Physics Statistics etc. or related field with 35 years of working experience in Quality Assurance/Control.
• Minimum of 3 years experience in a regulated industry preferably Medical Device or Pharmaceutical Industry.
• Supervisor experience preferred.
• Knowledge of medical device regulations (including FDA QSRs ISO13485.
• Ability to use a wide assortment of QC inspection measuring and test equipment (calipers gauges micrometers and optical comparator) to assure components and devices are manufactured and functioning according to specification.
• Excellent mathematical skills (tolerance analysis sampling plans).
• Experience with measurement systems and statistical techniques to support Quality Control.
• Ability to read blueprints; GD&T skills preferred.
• Technical aptitude (i.e. able to read and comprehend technical documentation ability to comprehend and execute procedures demonstrated understanding of system documentation).
• Working knowledge of critical Quality System elements related to Quality including CAPA Control of Nonconforming Product Batch Record Review Change Control and Quality Control.
• Quality certification (CSSGB CMI CQE CQT or CQA preferred but not required).
• Ability to effectively communicate to all levels of management within the organization.
• Ability to communicate effectively (both written and oral) using English (or local language).
• Strong technical writing skills.
• Familiar with the MS Office Suite including Microsoft Visio and Project.
• Must be able to observe company policies and safety procedures at all times.
• Demonstrated ability to work crossfunctionally in a team environment.
• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer telephone fax and copy machine as well as other general office equipment.

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 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.

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; jobrelated 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 the 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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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 or call us at.

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