Quality Assurance Engineer II (Remote) - 2 Openings

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists :

Infant 2245071261

Sivanesan 224 369 0756

Title : Quality Assurance Engineer II (Remote) - 2 Openings

Location : Remote

Duration : 3 Months

This position will be flexible in any time zone (EST, CST, PST)

Description : SUMMARY :

SUMMARY :

This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigations.

ESSENTIAL FUNCTIONS :

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint.

Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.

to determining trends and systemic issues. Prepare and issue reports based on information analysis.

Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.

Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.

Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.

Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.

Support CAPA and maintenance activities for existing product lines.

Recommend and / or support projects for improvements to the quality system as approved by management.

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

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

Medical Device Experience with knowledge of 21CFR820 preferred.

Investigational research skills

Experience with any statistical software packages (Minitab a plus)

Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.

Knowledge and working application of FDA cGMP; ANSI / ISO / ASQC requirements; CMDAS (optional).

Knowledge and working application of reading and understanding blueprints and technical drawings.

Demonstrated strong analytical problem solving (Root Cause Investigations.

Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).

Computer competency in Word, Excel, Power Point, Minitab, Access and databases.

Ability to multi-task and methodically manage projects.

EDUCATION / EXPERIENCE REQUIRED

A Bachelor's degree in Engineering and 1-3 years of Medical Device experience

PHYSICAL DEMANDS

Able to exert up to 10 pounds of force occasionally.

Able to sit, stand, walk throughout the workday.

WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Client is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.

Some of those work rules include but are not limited to :

o Wearing a static protective smock at all times while in the manufacturing work area

o Working in close proximity to other employees.

o Working in an environment that is temperature and humidity controlled.

Purpose of this Role & Key Requirements / Day to Day life :

Looking for Evaluation, a process for verifying compliance, matching code, interacting with any regulatory experience is useful, critical thinking, and medical devices would be helpful, and handling CAPA.

This role is simply working to the internal team (Spectrum) and evaluation teams, analyzing everyone's compliance, and executing an investigation

Top Skills :

This is an entry-level position as well, so 2-5 years of experience is acceptable.

Industry experience, medical device

Background in Electro-Mechanical devices are flexible

Regulatory experience is nice to have

Medical Devices Industry Experience : No

Education : Bachelor's degree

of Years if required Experience : Min 2 years experience

Interview Process : 2 rounds (Video conference in MS Teams)

Hours of Operation : Normal

Travel Involved : No

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.

The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.