Sr. Quality Systems Engineer - 26484

Job Description

Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Systems Engineer for a 12 month + Contract . Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Seeking a dedicated contractor to support integration activities between our existing company and a recently acquired company with a primary focus on integrating the Quality Management Systems (QMS) of the two organizations.

Position Description (Principle Duties and Responsibilities)

• The Quality Engineer will provide expertise in the execution through the QMS to support the integration of the new acquisition through execution of QMS activities, review of artifacts, driving process and product changes through the change control process.
• The Quality Engineer will work closely with cross-functional teams including regulatory affairs, quality assurance and R&D to support the integration project.
• Drive the design control process to execute through the existing and new processes.
• Collaborate with the cross functional stakeholders on reviews with requirements, V&V, CSV, design documents.
• Drive safety risk assessment (sFMEA/Risk Plans)
• Support release management, DevSecOps processes to drive compliance.
• Create or review SOPs, work instructions, and forms

Requirements

• Proven experience in Quality Systems management within the medical device industry
• Strong understanding of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable regulations.
• Demonstrated experience in managing Quality System integrations post-acquisition.
• Excellent communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.
• Ability to analyze complex Quality System structures and recommend practical integration strategies.
• This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

Benefits:
401(k) matching
Comprehensive dental, vision, and health insurance
Flexible schedule options
Health savings account
Life insurance
Paid time off
Professional development assistance
Employee assistance and discount programs
Referral program
Retirement plan
Tuition reimbursement

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Contact us today to learn more:
*** Grand Rapids, Michigan: 616.254.8586
*** Tampa, Florida: 813.463.8850
***
*** Chat with us live:

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.\r\n\r\nBenefits:\r\n401(k) matching\r\nComprehensive dental, vision, and health insurance\r\nFlexible schedule options\r\nHealth savings account\r\nLife insurance\r\nPaid time off\r\nProfessional development assistance\r\nEmployee assistance and discount programs\r\nReferral program\r\nRetirement plan\r\nTuition reimbursement\r\n\r\niMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. \r\n\r\nExperience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!\r\n\r\nContact us today to learn more:\r\n*** Grand Rapids, Michigan: 616.254.8586\r\n*** Tampa, Florida: 813.463.8850\r\n*** Chat with us live: