Staff Quality Engineer, ECMP Workstream Leader

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.

TheStaff Quality EngineerECMP Work stream Leaderis a key role within the EnterpriseCompliance Master Plan (ECMP) having the responsibility of leading Change Control Work stream which includes lifecycle management for product changes and document controls for design and process documentation of the Quality Management System (QMS). This role willbe responsible forleading a team of individuals and partnering with global quality leaders to develop processes that result inattainingthe companys improvementobjectivesand growth strategies acrossmore than 15designmanufacturing and distributionfacilities and a diverse portfolio of leading medical devices. This role is crucial for ensuring the development manufacture and distribution of medical devices in compliance with corporate policies U.S. Food and Drug Administration regulations ISO 13485 the Canadian Medical Device Regulations (CMDR) the EU Medical Device Regulation Japanese Pharmaceutical Affairs Law and other applicable regulatory agencies.

RESPONSIBILITIES:

• Drive standardization & deploy world-class solutions to drive improved quality and compliance.
• Recognized as a leading expert and internal thought leader in the designated QMS area with high-level knowledge and broad comprehensive knowledge of other QMS disciplines. Leads major improvements to existing processes and develops or champions new systems concepts and procedures to solve unique and complex problems that have a broad impact on the business.
• Evaluate new regulations guidelines and industry standards and their impact on ECMP QMS Workstream processes; plan and effectively implement plans across the business to maintain compliance.
• Establish a global community of practice for the designated QMS area or collaborate with responsible people to enhance the existing community of practice including governance and oversight to ensure compliance and consistency in relevant sub-processes applicable to the designated QMS area. Collaborate with process owners and stakeholders in corporate divisions and sites to ensure the program is compliant executable and meets user needs.
• Ensure compliance of all process and digital improvements with all appropriate regulations and standards including FDA ISO 13485 CMDR EU MDR and PMD Act.
• Interact and coordinate activities with other departments external vendors and customers. Influences and collaborates across stakeholder groups in the areas of process / system improvements identify and implement opportunities. - Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure synergy and strengths across the global teams.
• Provides strategic direction and communication of the ECMP QMS work stream goals directives and policies to employees creating a clear vision and positive team-oriented environment resulting in the achievement of the companys goals and increased profitability.
• Demonstrates technical leadership as an inter-departmental resource coaching and teaching other Integra Leaders across all functions and geographies.
• Perform other related duties as expected.

QUALIFICATIONS:

• Bachelors Degree in Engineering or Sciences or relevant Technical Field required. Masters degree preferred.
• Minimum 10 years of experience in quality manufacturing or engineering or equivalent education and years of experience
• Strong experience leading deployment of enterprise quality management solutions
• Experience in FDA controlled environment.
• Strong collaboration and facilitation skills and experience working in a matrix environment.
• Ability to interface with technical and non-technical personnel.
• Knowledge of FDA QMSR ISO MDSAP EU MDR PMD Act and other applicable standards and regulations.
• This position could require up to 50% travel.

PHYSICAL REQUIREMENTS

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 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

There are no adverse working conditions associated with this position.

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 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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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

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 candidates 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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