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Summary

The **Quality Systems II Engineer** is responsible for supporting the site Quality Management System (QMS). Primary responsibilities include driving improvements to the QMS, having oversight of and ensuring compliance to the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. This role will provide training on QMS processes to the organization, champion the QMS and work on many phases or sub-tasks of projects or entire projects.

Supervision received:

This position is under the direct supervision of the Quality Engineering Manager. Works independently under general supervision, reviewed at project milestone and/or completion by senior management.

Essential Duties and Responsibilities:

+ Supports maintenance of the Quality management System, ensuring compliance with regulations and internal site and global procedures. Identifies gaps in the QMS and drives improvements to close gaps.

+ Maintains the Quality Manual and site Quality System related procedures, ensuring contents are compliant and appropriate for the business.

+ Identifies Noncompliance's, works with complaint handling, and CAPA Investigations.

+ Organizes and manages the plant internal audit system as the site Internal Audit Manager.

+ Supports external Quality System audits in key roles. Provides support and subject matter expertise during audits and inspections.

+ Assists in the initiation, processing, and completion of CAPA records in the electronic system.

+ Leads meetings and communications for CAPA updates, information, and concerns to keep CAPA timelines on track.

+ Responsible for collecting and reporting Quality Metrics on regular basis in accordance with established procedures.

+ Independently investigates, gathers data, and performs preliminary data analyses.

+ Reports on Key Performance Indicators to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.

+ Provides experienced quality assurance support to manufacturing, product development teams, procurement, and other functional areas.

+ Promotes the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measure System Analysis.

+ Keeps up with current and developing manufacturing and engineering trends that concern product quality.

+ Undertakes special projects as required and contributes to continuous improvement activities.

+ Supports and lead process improvement activities.

+ Writes reports and presents progress at project meetings.

+ Achieves goals within established budgets.

+ Plans projects or subtasks so they may be tracked and presented.

+ Attends various meetings and actions/communicates instructions and follow-ups.

+ Independently determines approach for completion of assigned tasks.

+ Coordinates and leads Quality Review meetings.

+ Communicates confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

Desire** **minimum Qualifications:

+ Bachelors in an engineering discipline recommended (Mechanical Engineering preferred) with minimum of 3 years' experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education.

+ Previous CAPA and/or quality systems/assurance experience and demonstrated use of quality tools/methodologies.

+ Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards.

+ Previous experience in high volume manufacturing environment.(Medical Device preferred)

+ Demonstrated project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality related issues in a timely and effective manner.

+ Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.

+ Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.

+ Must be able to read and write in English.

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 and 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

Salary Pay Range:

$71,300.00 - $97,750.00 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 **.** 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 (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 [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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