Manager/Senior Manager - Quality Assurance (#0126) Singulex
THIS JOB HAS EXPIRED Summary
Oversee and direct the design, development and implementation of a Quality Management System to comply with QSR and ISO regulatory requirements.
Drive the CLIA business by implementing and maintaining a robust Quality Assurance program for the lab business.
Develop and implement Quality System SOPs and processes to achieve ISO 13485 and 21 CFR 820 compliance.
Assist in the identification and management of Contract Manufacturers and sole source suppliers.
Manage the product realization Quality Assurance process for Life Sciences, CLIA, and/or Diagnostics business.
Oversee the validation program.
Coordinate, track and drive open CAPAs with stakeholders to closure.
Develop and implement QA deviation system for production processes.
Coordinate, track and drive open deviations with stakeholders to closure.
Develop and maintain QA files for CAPA, NCR, Deviations and audits.
Support development of the employee training program.
Provide employee training and track employee training progress.
Provide value added recommendations for financial performance improvements.
Support on-site audits by our customers and regulatory agencies.
Design, compile, analyze, trends and issue QA performance metrics reports.
Perform Incoming Quality Assurance inspection of raw materials and components.
Write and implement standard operating procedures and work instructions for QA actions.
Perform other duties as assigned.
BS/BA degree in Science or related field.
6+ years related QA and Quality Systems experience.
In-vitro diagnostic (reagents and instrumentation/software) and CLIA laboratory experience preferred.
Strong understanding of QSR and ISO regulatory requirements is required.
Strong understanding and experience with Design Control requirements is required.
Able to lead groups and work independently, without instruction.
Demonstrates leadership skills to develop and manage Quality Assurance personnel.
Experience with developing systems and processes to achieve compliance with ISO and QSR requirements.
Skilled at understanding and implementing Quality Systems within a regulated environment.
Demonstrated proficiency with Excel, PowerPoint, and Word programs is essential.
Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical information to a wide range of audiences.
ASQ CQE and CQA preferred.
Excellent cross-functional team participation skills.
Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communication.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Ability to inculcate the Singulex ?Top-5? core values and serve as positive example to team members and others within the organization.
Effective personal communication skills, shares knowledge with excellent training skills.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work with minimal supervision as a member of a team.
Commitment to quality.
||Alameda, CA |
THIS JOB HAS EXPIRED