Medical Device QA Engineer

Akkodis is seeking a Medical Device QA Engineer with a client in Skaneateles, NY-Hybrid for a 6-month contract.

Title: Medical Device QA Engineer

Location: Skaneateles, NY-Hybrid

Duration: 6-month Contract

Pay Rate: $28-$30/hr (The rate may be negotiable based on experience, education, geographic location, and other factors

Job Description • 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 • 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, PowerPoint, Minitab, Access and databases. • Ability to multitask and methodically manage projects.

Education/Experience Required • A Bachelor of Science degree in Engineering • 1-3 years of Medical Device experience

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance