QA Engineer I (Pharma/Medical Device/Healthcare)

Immediate need for a talented QA Engineer I (Pharma/Medical Device/Healthcare). This is a 06+months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-15976

Pay Range: $30 - $32/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigation.
• 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.
• The physical demands 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.

Key Requirements and Technology Experience:

• Key Skills;Root Cause Analysis (RCA) & Problem Solving, CAPA (Corrective & Preventive Action), Medical Device Quality Systems Knowledge, FDA regulations like 21 CFR 820, ISO 13485 / GMP, Complaint Handling / Post Market Surveillance, Documentation & Technical Reporting, Data Analysis & Trend Identification.
• 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.
• A Bachelor of Science degree in Engineering
• 1-3 years of Medical Device experience
• Must be able to sit for long periods of time
• Must have good hand to eye coordination and dexterity
• Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.
• Wearing a static protective smock at all times while in the work area
• Wearing a ground wrist strap and plugging that wrist strap into the working table.
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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