Manufacturing Quality Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

Akkodis · 21 hours ago

Manufacturing Quality Engineer

Akkodis is seeking a Manufacturing Quality Engineer for a 12-month contract position. The role involves ensuring quality compliance in the manufacturing process, managing supplier quality, and leading continuous improvement initiatives.

Information Technology & Services
check
H1B Sponsor Likelynote
Hiring Manager
Akash Jaiswal
linkedin

Responsibilities

Areas of responsibility may include: non-conforming product, CAPA, calibration systems, supplier auditing, sterility assurance, and improving measuring techniques, design of gages, training, statistical support, quality planning, experimental protocols, and facilitation of root cause analysis, risk assessment and complaint investigation
Implement and maintain Quality System requirements on assigned areas of manufacturing, supplier management, inspection planning and process validation
Know and follow all laws and policies that apply to one’s job and maintain the highest levels of professionalism, ethics and compliance at all times
Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions
Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams
Provide quality reports and review trending on assigned areas of responsibility
Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs)
Review and approve documents and drawings for manufacturing and product development (DCOs, MCs)
Familiar with the “Change Control” process(s)
Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of products
Design gauging and develop tools and techniques to measure product parameters to assure product complies with engineering drawings
Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities
Develop and document Quality Plans to support product acceptance activities
Facilitate creation of risk management documents
Ensure compliance issues are addressed for product activities
Participate on design reviews and risk analysis for product changes
Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness
Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval
Provide guidance to others for the generation of clear, concise and defendable protocols and reports
Assist in determination of the need for validation
Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting
Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s)
Coordinate and participate on supplier audits and technical assessments
Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations
Administrate Supplier Management Program and measures effectiveness
Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions
Coordinate Quality Plans and inspection/test methods between suppliers and Synthes
Visit suppliers for the purpose of quality issues investigation and capability analysis
Assist purchasing in resolution of supplier complaints

Qualification

ISO 9001FDA QSRGeometric DimensioningStatistical Process ControlLean ManufacturingSix SigmaQuality Plan DevelopmentBasic MetrologyBlueprint ReadingGage DesignDesign FMEAProcess CapabilityDesign of ExperimentsGage R&RManufacturing Materials

Required

A minimum of a Bachelor's degree in Sciences, Business, Engineering or related technical field

Preferred

A minimum of 1 year (professional, internship, co-op, etc.) experience working in a quality system framework (ISO 9001 or similar)
Medical device/diagnostic/or pharmaceutical; regulated industry experience
Knowledge of FDA's QSR and ISO regulations
Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development
Knowledge of Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments
ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification
Knowledge of Manufacturing materials and removal processes (machining, sheet metal, electro polishing, passivation, hard coating, cleaning, adonization, etc.)

Benefits

Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
An EAP program
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay

Company

Akkodis provides digital engineering solutions for sustainable and innovative industries.

H1B Sponsorship

Akkodis has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (121)
2023 (67)

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Lane Greever
Chief Operating Officer (COO), Americas
linkedin
leader-logo
Kishore Raj
Vice President & Partner: Technology and Engineering Consulting and Services
linkedin
Company data provided by crunchbase