Quality Systems Specialist

Compensation

: $114,900.00 - $162,750.00 /year *

Employment Type

: Full-Time

Industry

: Manufacturing



Job Summary* The Quality Systems Specialist will support Magellan's Quality Policy and Magellan Operating Procedures and provide effective solutions for success. This individual will be actively involved with Quality System Management, Quality Improvements and must have a constant awareness of Customer Requirements. The Quality Systems Specialist must be oriented to make metric-driven decision making; maintain accurate and concise record keeping; uphold 21 CFR Part 820 and ISO 13485 requirements; partner with internal customers and suppliers; demonstrate progressive activity toward developing a meaningful career; and supporting management decisions concerning growing the Magellan Business Strategy. Also, they will implement and maintain the Documentation Control system, which includes the electronic Documentation Management system. Revision Control, processing ECO's, and updating the affected drawings and specifications. All tasks are performed in compliance to 21 CFR 820.40 Subpart D - Document Controls.Key DutiesEssential Functions:* Perform Quality System audits.* Identify improvement opportunities and implement change* Quality Management functions (i.e. CAPA's, Internal and External Audits, Complaint Investigations, Product release, MRB, Quality reports, regulatory registration support as needed) using basic Quality Assurance principles and methodology under the guidance of the Quality Assurance Manager.* Ensure compliance with the organization's policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and Marketing to improve product quality to meet current cGMP standards.* Develop and maintain standard operating procedures (SOPs). Review ECOs and other documents for accuracy, approve and reject tasks, notify initiator/author when training can be completed. Review and process as needed manufacturing/test procedures for products and raw materials for release into inventory and shipping. Organize and track the training program for all employees.* Create and maintain BOMs and item master in ERP system.* Maintain records and indexes of all documents stored off-site.* Assure all 510(k)s, DHF, Validations and master document files are in a locked, controlled environment, with access limited to Quality Assurance employees and other department officials on an as needed basis.* Prepare materials as needed for 3rd party audits and maintain objective evidence documents.* Update management with bi-weekly and quarterly metrics as defined by the QA Manager.* Other duties as assigned.Supervisory Responsibilities:* NoSuccess Factors:* Must be able to work with minimal supervision from management. Excellent ability to collaborate to achieve objectives and problem-solve. Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices. Understanding of various software programs required to document existing and new documentation.* Able to handle highly confidential messages and correspondence.* Must possess outstanding communication (verbal and written), interpersonal, problem solving and customer service skills.* Detail-oriented with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.* Must be self-starter, able to prioritize and handle multiple tasks and ability to meet strict deadlines and perform under pressure in a fast-paced work environment.* Good problem solving and troubleshooting skills.* Must be able to work overtime and weekends as necessary to support departmental efforts.QualificationsRequirements (Physical, Mental, Environmental Demands):* Must be able to wear personal protective equipment (lab coat, latex or nitrile gloves, safety glasses, etc) when on the production floor* Must be able to adhere to applicable biosafety practices when on the production floor or in laboratories* Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.* Ability to travel by car/air to other locations to conduct inspections, training or investigations.* Ability to work on PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day* Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Associated topics: infrastructure, maintain, maintenance, network, satcom, server, system engineer, system specialist, system technician, technician * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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