Quality Assurance Manager for Manufacturing and FDA Medical Device Regulations

New
  • Location
    Moberly , Missouri
  • Category
    Engineering - Quality
  • Job type
    Contract/Temporary


Position Details

Position: Quality Assurance Manager

Location: Moberly, MO (65270) No relocation assistance or travel expenses can be offered

Duration: 3 Months (Temp to Perm)

Compensation: $40.86-$52.88/hour - No per diem, relocation expense reimbursement or other expense reimbursement can be offered


**Must be eligible to work for any employer in the U.S. without sponsorship / no corp to corp or 3rd party contracting arrangement / Adecco W2 only.


Job Summary
The company is a medical device manufacturer. The incumbent must be able to work closely with management at BU and facility levels. The incumbent works with corporate functions of Regulatory Affairs, Professional Services, Quality Systems and Standards, Technical Management, as well as BU Sales Marketing, Finance, and R&D. Provides information to maintain technical files on products for international standards and regulations, to Professional Services for product condition and customer satisfaction, and to Corporate Quality Assessment on facility conditions and quality systems. Also works with outside support plants, service and component suppliers, customers and serves as Site Management Representative. Reports to the Director of Quality Assurance. Works cross-functionally with the Plant Manager on matters such as staffing, organization structure, budgeting, and strategic planning. Incumbent must comply with regulatory requirements, policies and procedures, as they apply to the position.

• Designing and implementing Quality systems which comply with Corporate Policies, training staff and key personnel in order to attain strategic objectives, along with providing management quality trend information to aid in achieving these objectives.
• Managing and developing all personnel within the Quality function in order to maintain and improve overall efficiency of plant operations.
• Supervise and support product validations and designs
• Establishing documentation required for the implementation and maintenance of quality systems and compliance to applicable International standards, such as ISO13485, ISO 17025, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, J-GMP (i.e., PAL) and other as applicable.
• Perform Risk Assessment, as applicable, following ANSI/AAMI/ISO 14971 standard.
• Providing support for the administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility.
• Initiating and directing corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action.
• Providing liaison between the operations management and applicable regulatory agencies regarding audit findings, litigation, and complaints.
• Establishing and implementing quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation.
• Improve facility operations through implementations of quality management specifications, procedures, test methods, and measurement systems.
• Minimize customer complaints due to product quality through effective corrective action systems
• Ensure compliance of plant operations to appropriate regulations and standards and act as site management representative.
• Work cross-functionally with all other business unit functions by maintaining productive working relationships and promoting QA involvement.
• Manage departmental spending with the budget.
• Manage, supervise and develop direct reports.
• Ensure all key items for maintaining ISO and CE certifications are addressed: serve as main contact for external agencies, coordinate effective management reviews, including gap analyses, coordinate training of the Quality Systems, and support the maintenance of the associated product Technical Files. Designated Management Representative.
• Evaluate the impact of any new product or changes to existing products on regulatory applications.
• Comply with local and federal Environmental, Health and Safety Regulations, such as OSHA, EPA and other standards and guidelines.
• Direct supervision of Quality Assurance personnel.

Position Requirements:
• Bachelor’s Degree, preferably with emphasis in electrical or mechanical engineering.
• 5+ years of experience in Quality Management and Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistics and sampling methods.
• 3+ years of experience in the medical device industry, or manufacturing experience are preferred. Previous experience with FDA and notified body audits is helpful.
• Six Sigma Engineer or ASQ Certification in Quality Engineering or Quality Management, preferred.
• Able to work under pressure, multiple tasks, and deadlines
• Experience in the application of statistical methods and techniques such as statistical process control, design of experiments and problem-solving techniques are helpful.
• Knowledge of applicable standards (i.e., ISO 13485:2003, MDD, QSR’s, GMP’s, and CMDR) is also required.


**Successful completion of a full background check, drug screen, employment verification, educational verification and reference checks required upon offer.


How to Apply
Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

If you have any questions surrounding the application process, please feel free to contact Melody Meyer at melody.meyer@adeccona.com

Why Adecco? Because Adecco provides one of the most COMPREHENSIVE BENEFITS package in the industry to contract workers. Just take a look at a few of the benefits available to you as a contractor:
Medical Coverage – access to an affordable and comprehensive group medical coverage plan
401(k) – Adecco offers all temporary employees the ability to participate in a 401(k) savings program
Pay Options/Direct Deposit – we make it as easy as possible for you to get paid
Paid Holidays – selected paid holiday, based on accrued hour requirements
State-of-the-artCareerCenter– training and resources available for all employees
Highly trained and professional staff – Our team cares about you and your career!

In addition to the position above, please feel free to look at all Adecco opportunities by visiting www.adeccousa.com.

Adecco is an equal opportunity employer. The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions.

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Reference number US_EN_2_022862_393889