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Quality System Specialist (Account Executive II)
Ref No.: 18-07596
Location: Richmond, California
This position will provide both direct support for key Document Control systems associated with our QMS as well as assist the QA Management team with administrative activities (e.g. process payroll, requisitions, manage calendars, schedule meetings and create agendas, etc.).

Responsibilities include: Control and Maintain the electronic Change Order Process, review and approve DCOs and ERs; develop and/or revise SOPs and WIs; organize, support and/or serve as auditor for the LSG Internal Audit Program; perform activities related to tracking and review of nonconformances and deviations; provide support to our internal customers and provide direct support to the Quality Assurance (QA) Department
  • Reviews and compiles batch records (i.e. DHRs) for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements. Identifies and documents deviations as appropriate.
  • Maintain and archive controlled documentation and completed quality records. Provide access to controlled documents as per procedure(s).
  • Provide support during external audits or inspections
  • Supports activities related to the Change Control Process at the site.
  • Works with operations personnel to investigate, document and manage deviations, non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate with a willingness to improve quality procedures and methods.
  • Assists with performing internal audits and investigations.
  • Analyzes and prepares data for reports and recommendations for management reviews.
  • Assists with Quality System projects as necessary.
  • Supports databases and systems used for tracking various QMS activities.
· A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.
· Requires 3+ years related experience.
· Experience working in both an FDA and ISO 13485: 2016 is desired.
· SAP experience a plus
· Proficient in Microsoft Word, Excel, PowerPoint and project planning tools.
· Relevant experience working in manufacturing/operations is required
  • The ability to effectively communicate issues to both technical and non-technical audiences.
  • Strong planning, organization, problem solving and time management skills required.
  • Must have excellent analytical and communication (written and verbal) skills as well as highly effective interpersonal skills;
  • Able to work independently and make informed decisions regarding daily operations without direct intervention from a supervisor.
  • Able to manage multiple and varied tasks with a high level of specificity and also prioritize workload and report on progress.
  • Ability to work in a project/team environment through utilization of solid decision-making and conflict resolution skills.
  • Strong customer focus and ability to work effectively with cross-functional groups;