Quality Engineer II

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.

Essential Duties And Responsibilities

• Proficient in one or more key Quality Engineering areas (e.g., Process Validation, Change Control, Control of Nonconforming Product, CAPA (corrective & Preventative Actions) Process Controls, Measurement Methods and qualifications).
• Assist or lead in the identification, investigation, root cause analysis activities, implementation, and effectiveness verifications of CAPA.
• Assist or lead Control of Nonconforming Product process activities (e.g., disposition review/approval & containment action activities).
• Evaluate impact assessments/risk assessments as it pertains 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 Order review and approval as necessary for New Product Introduction).
• Identify statistically based sampling plans for inspections and validations.
• Assist in the implementation of SPC control system with Manufacturing and Quality Control
• Support validations for new and existing products, processes and equipment (document/change order reviews & approvals).
• Establish and maintain Quality Management System procedures related to areas of responsibilities.
• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR and other applicable regulations/standards.
• Support Internal Audit program.
• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
• Identify and implement opportunities for continuous improvement.
• Collection and reporting of metrics and data as required.
• Performs other Quality Management System related duties as required.
  
  

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

Desired Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Education & Experience:

• BS/BA degree with 3-5 years of working experience in Quality Assurance/Control or Manufacturing environment required.
• A minimum of three years’ experience in a regulated industry is required, preferably Medical Device Industry. required.
• Certified Quality Engineer, preferred.
• Working knowledge of Quality System elements of CAPA, Control of Nonconforming Product, Change Control, and Quality Control.
• Experience providing on the floor support to Operations, Manufacturing Engineering, and/or Quality Control required.
• Must have the ability 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 is preferred.
• Experience with leading CAPA investigations is preferred.
• Working knowledge of medical device regulations (including FDA QSRs, ISO13485) is preferred.
• Experience in High Precision machining process is highly desired.
• Ability to communicate effectively (both written and oral).
• Strong technical writing skills are highly desirable.
• Familiar with the MS Office Suite, including Microsoft Visio and Project.
• Must be able to always observe company policies and safety procedures.
• Demonstrated ability to work cross-functionally in a team environment.
• Ability to work independently with little supervision.
• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
  
  

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.

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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 careers@integralife.com or call us at 855-936-2666.

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