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Senior Quality Engineer.US-CIN.003

Posted on Jan 9, 2022 by Integra LifeSciences

Cincinnati, OH
Immediate Start
Annual Salary

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily.  Other duties may be assigned.

Subject Matter Expert for one or more key Quality Engineering areas (e.g., Process Validation, Change Control, Control of Nonconforming Product, Process Controls, Measurement Methods and qualifications).

Assist or lead complaint handling activities (e.g., investigations).

Assist or lead in the identification and implementation of CAPA.

Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).

Facilitate the execution of Risk Management activities.

Support new product development and production (e.g., Change Order review and approval).

Provides support necessary for supplier controls, including but not limited to, supplier audits.

Identify statistically based sampling plans for inspections and validations.

Aid in the implementation SPC control system with Manufacturing and Quality Control

Support validations for new and existing products, processes and equipment.

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.


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

BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 7-10 years of working experience in Quality Assurance/Control.

Minimum of five years’ experience in a regulated industry, preferably Medical Device Industry.

Certified Quality Engineer, preferred.

Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product).

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.

Experience with CAPA processes including investigational techniques.

Experience with Complaint Handling processes, especially investigations.

Experience with Risk Management regulations and application (ISO14971).

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

Strong knowledge on Risk Management tools as per ISO14971: 2012.

Experience in High Precision machining process is highly desired.

Ability to communicate effectively (both written and oral) using English (or local language).

Strong technical writing skills.

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

Must be able to observe company policies and safety procedures at all times.

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.

Reference: 61052838

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