Lead Quality Inspector

integralife; Plainsboro Township (NJ); On-site; USD 36,000 - 48,000; Full time

Job summary

Integra LifeSciences seeks a Weekend Lead, Quality Inspector for the Plainsboro Manufacturing Site (CMC). The Lead Associate will supervise QC inspections of components, sub-assemblies and finished products, train inspectors, and ensure compliance with FDA, ISO 9001, ISO 13485 and related regulations.

Shifts are Fri–Sun 6:00 AM–6:30 PM (40-hour compensation). Responsibilities include scheduling inspections, addressing non-conformances, supporting CAPA investigations, coordinating with

Qualifications

• Minimum of 5+ years' experience in document management using electronic document management systems or manual systems with electronic storage.
• Minimum of 5+ years’ experience in a Quality Systems / Regulatory Compliance environment with knowledge in medical device, diagnostics or pharmaceutical industries; familiarity with FDA regulations and ISO quality standards.

Responsibilities

• Oversee daily activities in the QC department.
• Prepare the QC Inspection schedule to ensure manufacturing areas are covered to meet production schedule.
• Report non-conformances in a timely manner.
• Support NCs and CAPA investigations as required.
• Assist with product flow between departments.
• Coordinate inspections with Manufacturing to ensure timely completion.
• Propose revisions to SOPs for new processes or improvements.
• Train QC Inspectors as required.
• Perform inspections (incoming, in-process, first article, etc.) using inspection equipment to determine acceptance or rejection.

Skills

Document management

Quality systems

Communication skills

Microsoft Office

Tools

Oracle R12/Agile

Job description

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 Lead Quality Inspector serves as a Lead Associate, Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center (CMC). The lead associate is responsible for performing and/or scheduling quality assurance inspections on purchased components, manufactured sub-assemblies and final product. Expectations are to be familiar with and be able to measure critical dimensions as well as to train new quality inspectors and provide guidance to current quality inspectors. Lead Associate, Quality Inspector will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.

This is for a Weekend Lead, the Shift is 12 hours on Friday, Saturday and Sunday from 6am to 6:30pm (will be compensated for 40 hours per week)

Job Responsibilities

• Oversee daily activities in the QC department.

• Prepare the QC Inspection schedule to ensure that all manufacturing areas are covered in order to meet production schedule.

• Reports any non-conformances in timely manner.

• Support NCs and CAPA investigations as required.

• Assist with product flow between departments.

• Interface with Manufacturing department in order to coordinate inspections of completed product to ensure the inspections are done in a timely manner.

• Initiate and /or propose revisions to standard operating procedures involving new processes or process improvements.

• Train QC Inspectors as required.

• Perform inspections (incoming, in-process, first article, etc.) by using a variety of inspection measuring equipment to determine acceptance or rejection of material or parts.

• Interpret and work within the guideline of drawings, specifications, charts, procedures, and other date to determine product or material acceptance.

• Read and interpret sampling plan as per the American National Standard Institute (ANSI).

• Oversees physical and electronic quarantine locations.

• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• Minimum of 5+ years' experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage.

• Minimum of 5+ years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.

• Capable of both written and verbal effective communication skills.

• Proficient in the Microsoft Office suite of products.

• Proficient in Oracle R12/Agile preferred.

Salary Pay Range:

$26.21 - $35.38 USD Hourly

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 https://jobs.integralife.com/total-rewards/

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 [e-mail].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo