Integra LifeSciences

Staff Quality Engineer

US-MA-Braintree-220-Facility · Staff+

Sponsorship not specified$109k-$150kDetected 30 days ago

StatisticsBrand StrategyProcess ImprovementRecruitingControlsFDA RegulatoryMedical DevicesMentoringRegulatory Affairs

About the role

Thinking differently is what we do best.
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.
Responsible for equipment and process improvement projects, supporting introduction of new processes or equipment into the facility.

Responsibilities

Seasoned professional with complete and in-depth conceptual and practical knowledge in providing quality and engineering support decisions in a manufacturing environment.
Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development, and task force projects.
Leads multi disciplined Team in the development and execution of Process FMEA and other applicable risk analysis as deemed appropriate.
Develop, Collect, Analyze, and report Quality Metrics.
Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports.
Ensure that all projects are compliant with GLP, QSR (including Design Controls), ISO or other applicable requirements.
Identify and implement opportunities for continuous improvement.
Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met.

Requirements

7 years' direct QE experience in a regulated med device, life sciences or pharma industry.
7 years' direct experience in dFMEA and pFMEA.
5 years' direct experience w/ ISO 13485, ISO 14971, FDA QSR.
Probability & Statistics Working usage and knowledge of Probability & Statistics.
Support as required the Quality Management Review Process.
As required, assist or lead in the prompt implementation of Non-Conformance resolution.
Perform other Quality Systems related duties as required.
Perform other duties as required.

Nice to have

5 years' experience w/ SPC (Statistical Process Control).
Preferred professional certifications - CQE, CQA, CRE.

Compensation

$109,250.00 - $149,500.00 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.
Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.

Company info

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
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 careers@integralife.com.
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.
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.
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.

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This listing is sourced directly from Integra LifeSciences's careers page and normalized into a canonical job model.