Manager, Site Quality Leader

Integra LifeSciences; Prospect (CT); On-site; USD 95,000 - 130,000; Full time

Job summary

Integra LifeSciences seeks a QA professional to lead critical Quality areas in the Prospect, CT facility. You will drive CAPA, Change Control, and documentation control to ensure compliant product manufacturing and timely issue resolution.

You will provide QA on-the-floor support to Operations and QC, participate in audits and inspections, and help maintain the Quality Management System in a regulated environment. Strong writing and communication skills are essential.

Qualifications

• BS degree in Engineering, Math, or Science with 5+ years in QA/Quality Control.
• Minimum of 5 years in a regulated industry, preferably Medical Device.
• Working knowledge of QA elements related to QA Engineering (CAPA, CoNforming Product, Change Control, Validation, Quality Control).
• Experience with measurement systems and statistical techniques to support Quality Control.
• Experience leading CAPA investigations.
• Working knowledge of medical device regulations (FDA QSRs, ISO13485).
• Strong communication and technical writing skills.
• Proficiency with MS Office Suite, including Visio and Project.

Responsibilities

• Lead CAPA investigations and effectiveness verification.
• Oversee Control of Nonconforming Product (disposition, containment) processes.
• Evaluate impact and risk assessments related to CAPA/NCMR.
• Provide on-the-floor QA support to Operations, Manufacturing Engineering, and QC.
• Support new product development and production with Change Control.
• Assist in validations for new and existing products, processes and equipment.
• Lead Quality representations on projects and meetings.
• Maintain Quality Management System procedures.

Skills

CAPA

Change Control

Control of Nonconforming Product

Quality System

Documentation

Education

BS degree in Engineering/Math/Science

Tools

MS Visio

MS Project

Job description

US-CT-Prospect-facility

Full time

JR-6828

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.

SUMMARY DESCRIPTION

The Quality Assurance group is dedicated to ensuring product compliance in support of site Manufacturing and Operations. This includes managing critical Quality System elements such as CAPA, Control of Nonconforming Product, Change Control, and Quality Control, Validation, and Compliance. The team collaborates closely with Operations and Manufacturing Engineering groups to maintain high product quality, maintain compliance, and implement effective and efficient corrective and preventive actions as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Subject Matter Expert and leader for key Quality areas including Process Validation, Change Control, Control of Nonconforming Product, & CAPA (Corrective & Preventative Actions), and Document Control.

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

• Assist or lead in the identification, investigation, root cause analysis, implementation, and effectiveness verification of CAPA.

• Assist or lead Control of Nonconforming Product process activities (e.g., disposition review/approval and containment action activities).

• Evaluate impact assessments and risk assessments related to CAPA and NCMR.

• Provide QA on-the-floor support to Operations, Manufacturing Engineering, and QC as needed.

• Support new product development and production (e.g., Change Control review and approval for New Product Introduction).

• Support validations for new and existing products, processes, and equipment (document/change order reviews and approvals).

• Assist in measurement methods, MSA, TMVs, and GRR.

• Lead Quality Representative on projects & meetings

• Establish and maintain Quality Management System procedures related to areas of responsibility.

• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/standards.

• Lead audits for the Internal Audit program.

• Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.

• Identify and implement opportunities for continuous improvement.

• Collect and report metrics and data as required.

• Perform other Quality Management System related duties as required.

Note: Other duties may be assigned as necessary.

DESIRED MINIMUM QUALIFICATIONS

The following qualifications represent the knowledge, skills, and abilities required for this position:

Education & Experience:

• BS degree in Engineering, Math, or Science (Biology, Chemistry, Physics, Statistics, etc.) with 5+ years of working experience in Quality Assurance/Control.

• Minimum of 5 years’ experience in a regulated industry, preferably the Medical Device Industry.

• Working knowledge of critical Quality System elements related to QA Engineering, including CAPA, Control of Nonconforming Product, Change Control, Validation, and Quality Control. In addition, provide a high level of QA on the floor support to Operations, Manufacturing Engineering, and Quality Control.

• Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

• Experience with measurement systems and statistical techniques to support Quality Control.

• Experience leading CAPA investigations.

• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

• Experience in high precision machining processes is highly desired.

• Ability to communicate effectively skills (both written and oral) in English (or local language).

• Strong technical writing skills.

• Proficiency with the MS Office Suite, including Microsoft Visio and Project.

• Ability to consistently observe company policies and safety procedures.

• Demonstrated ability to work cross-functionally in a team environment.

• Ability to work independently with minimal supervision.

• Must treat others with respect, work with integrity and ethically, and 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

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.

The physical requirements listed in this section include, but are not limited to the motor/physical abilities and skills require 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.

ADVERSE WORKING CONDITIONS

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.

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.

Salary Pay Range:

$95,000.00 - $130,000.00 USD Salary

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.

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 (https://www.integralife.com/careers/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 (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

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Whatever your specialty, you’ll find an ideal setting for building a rewarding career.

Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating - because the need is so urgent. You’ll be challenged - and supported - by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.