Quality Engineer

Integrated Resources Inc.; Mansfield (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading staffing firm is seeking a Quality Engineer in Mansfield, Ohio for a 6+ month engagement. The successful candidate will manage risk related activities and quality support for medical devices, leveraging their experience with regulations and cross-functional collaboration. This role demands significant expertise in quality engineering and risk management.

Benefits

Referral bonus of $500

Qualifications

• 4+ years of experience in medical devices.
• Knowledge of FDA 21CFR820, ISO13485 regulations.
• Experience with electro-mechanical devices preferred.

Responsibilities

• Lead risk management activities and product quality analysis.
• Collaborate with cross-functional teams to maintain risk management files.
• Support CAPA initiatives and product performance improvements.

Skills

Risk Management

Quality Engineering

Continuous Improvement

Collaboration

Negotiation

Conflict Resolution

Education

B.S. in Engineering

Tools

ISO14971

IEC 60601

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Title: Quality Engineer

Location: Mansfield, MA
Duration: 6+ months (possibility of extension)

JOB ROLES & RESPONSIBILITIES:

· This position will lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues and carrying out continuous improvement efforts.

· Primary responsibilities for this position include risk assessment, maintenance, and management as documented within the risk management files, providing post market quality support and guidance through nonconformity assessment, supporting health hazard assessments, and contributing to the various aspects of CAPA such as containment determination, root cause investigation, and corrective action planning by utilizing their subject matter expertise across the organization.

ESSENTIAL FUNCTIONS:

· Support, Collaborate and drive post market quality activities with cross functional partners (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch.

· Collaborate with Clinical personnel on creation of appropriate harm/hazard analysis (HHA and RMF) for issues potentially impacting users and patient outcomes. ? Provide assessment of post-market risk related to field issues and provide response to regulatory body inquiries as necessary.

· Support Post Market activities related to product design and production in accordance with applicable procedures.

· Initiate, drive, or support CAPA related to product performance, compliance, or continuous improvement.

· Maintain knowledge base on new regulations and standards that affect Risk Management for medical devices.

· Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including Quality, R&D, Marketing, and Medical/Clinical Affairs.

· Ensure Risk Management Files are maintained per defined schedules and frequencies.

MINIMUM REQUIREMENTS:

· Education required/ preferred: B.S. in Engineering or associated scientific discipline.

EXPERIENCE

· Minimum 4 years medical devices experience in Quality or Development Engineer position.

SKILLS/COMPETENCIES:

· Working knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, dFMEA, etc.).

· Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR820, ISO13485)

Other Skills:

· Working knowledge of electro-mechanical devices, software hazards analysis, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.

· Mastery of software programs - Microsoft Word, PowerPoint, Excel, and Project.

· Demonstrated ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives.

· Broad business knowledge and ability to link customer needs with business.

· Self- starter, with the ability to work independently and with all levels of managers, associates, and clients.

· Proven ability to directly lead and/or co-lead multiple tasks and projects.

· Strong collaboration, negotiating, and conflict resolution skills.

Additional Information

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724
Email id – seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)