Quality System Engineer

2 weeks ago

Flowery Branch, United States medmix Full time

We are looking for a Senior Quality System Engineer to join us at medmix. This exciting opportunity will allow you use your skills to identify areas of improvement and propose recommendations to management. You will lead and drive the implementation of your recommendations and assess its impact to the business. If you are eager to learn, strive for personal development, are highly motivated and organized, and a great communicator, you can help us drive medmix to the next level.

Job Description

The Quality Systems Lead is responsible for supporting the Healthcare business by developing and executing a compliant ISO 13485/21 CFR 820 quality system. We are looking for an experienced Quality Systems Manager with a strong background in the manufacturing industry. The ideal candidate is a highly motivated individual with the ability to work across teams to ensure that the organization's quality systems are managed in the most effective way possible. This position requires great attention to detail and a commitment to effective processes.

Main Accountabilities and tasks

  • You will lead a team to manage day to day maintenance of the quality management system but also to develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
  • Overseeing and ensuring an effective complaint, nonconformance, CAPA, document management and records systems
  • Drives root cause investigations, provides compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations.
  • Aids in Management Review preparation.
  • Reviews and approves complaint investigation and root cause, CAPAs.
  • Analyze, trend, and report data supporting the quality system (KPI’s).
  • Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers.

Qualifications

Work Experience: 3-5 years of validation experience in a regulated manufacturing environment related to quality control of medical devices per ISO 13485 and 21 CFR 820.

Education: BS degree

Other:

  • Experience with injection molding processes, parameters, and troubleshooting is preferred.
  • Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
  • Required experience with good documentation practices and cGMP standards.
  • Thorough understanding of ISO 14971 from implementation through device lifecycle.
  • Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software.
  • Experience working in a clean room environment and performing process and equipment validations.
  • Ability to perform work accurately and thoroughly and to work independently with minimal supervision.
  • Must be organized and able to follow a systematic method of performing tasks and the ability to organize and direct a project to completion.
  • Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.
  • Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
  • Ability to work well with subordinates, peers and superiors in all departments.

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