30 Sep
Missouri,
Moberly
, 65270
Moberly
USA
Vacancy expired!
Job#: 1296580 Job Description: Apex Systems is seeking a QA Manager for a 8+ month contract opportunity with our client in the medical device industry in the Moberly, Missouri area!For immediate consideration, please send resume to Robbie at and reference job #1296580.Duties:The incumbent is responsible for the quality management function within Moberly, Missouri. The implementation and administration of quality management programs for production operations associated with Thermal Therapy products is the responsibility of the Quality Management Manager.The incumbent works closely with the Plant Operations Staff regarding product and service quality decisions. The Incumbent maintains communication with the Director of Quality Management, for assistance in resolving major quality problems, and to keep the Director informed regarding quality activities within and outside of the manufacturing plants. The incumbent is also responsible for maintaining compliance systems to cGMP and ISO requirements at the manufacturing facility. The incumbent must be able to work closely with management and functions at the business unit level. The incumbent also works with outside support plants, private-label customers, and raw material suppliers.The effectiveness of this position can be measured by the following:- Overall output and effectiveness of the plant operations.
- Overall quality system effectiveness as measured through internal, Group, and external assessment reports.
- Quality trend data on first pass quality, DPM's, complaint levels, and overall cost of quality.
- Problem solving and root cause analysis ability.
- Expense control within Quality department budgets.
- Reports to the Director of QRA Management.
- Site Management Representative
The Management Representative has responsibility and authority that includes:Ensuring that processes needed for the quality management system is documented;Reporting to top management on the effectiveness of the quality management system and any need for improvement;Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization;Ensuring the Quality System requirements are continuously met and maintained at the facility, and the product meets all requirements of the Quality System Regulation and ISO.Skills:Manager, Quality Management:- Design and implement Quality systems which comply with corporate policies, train staff and provide quality trend information.
- Manage and developing all personnel within the Quality function.
- Validate product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.
- Establish documentation required for the implementation and maintenance of the full quality system in accordance with CFR Title 21 Part 820. ISO 13485:2016, Canadian Medical Device Regulations, applicable International Standards and Council Directives.
- Ensure compliance of General Office and facility activities to appropriate regulations and standards (FDA, ISO, EN).
- Establish and implement quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, process improvement, quality, service, and innovation.
- Communication, multi-task management, and leadership skills are required for effective performance in this position.
- This position will serve in a results-driven environment and requires a team-oriented individual.
- The position facilitates team-based management developing support relationships with all departments, functions, and personnel in dealing with quality problems, initiatives, and corrective actions.
• Initiate and direct corrective actions to problems relating to product or process quality.- Ensure all key items for maintaining ISO certifications are addressed.
• Coordinate effective management reviews, including gap analyses.• Evaluate the impact of any new product or changes to existing products or processes on regulatory applications.Must be able to manage and complete other duties as assigned.Education:This position prefers a- Bachelor's degree, in engineering or related and 5 years of experience
OR- Master's degree in engineering or related with 2 years of experience with the following: Quality management & Regulatory Affairs, medical devise manufacturing, FDA (CFR 820) & ISO/EC.
EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or
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