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

SUMMARY DESCRIPTION

The Quality Inspector I will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.  

Position is a 4 day/10hour shift (M-TH)

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
• Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
• Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
• Read and interpret sampling plan as per the American national standard institute (ANSI).
• Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
• Maintain accurate and current inspection and/or testing records such as and not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
• Assist with reviewing inspection reports, completed Quality forms, logbooks, and associated Quality forms.
• Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
• Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
• Maintain records of inspection and all testing performed on the appropriate test records.
• Assist in physical moving and labeling of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
• Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• High School Diploma.
• QA experience in the medical device industry preferred.
• Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred.
• Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to work effectively in a cross functional environment.
• Ability to integrate quality objectives across multiple functions.
• Attention to detail and strong time management are essential.
• Must be able to work independently with minimal supervision.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write in English.  The employee is required to go to all areas of the company. Employee is required to enter cleanrooms while adhering to Standard Operating procedures.  The employee may be required to periodically lift and/or move up to 50lbs.

Important: Role requires employees to pass a visual acuity test. Vision aids, such as glasses or contact lenses, are allowed and must be worn during visual inspections if needed to pass the test.

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Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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 | 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].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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