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QA Specialist / Associate - Luminex Molecular Diagnostics (Toronto)
Position based in Toronto
JOB SUMMARY:
Responsible for Quality Assurance operations associated with Luminex products and processes specifically documents and records coordination. A strong knowledge of the quality management system is required.
MAJOR RESPONSIBILITIES:
- Managing the Internal Quality Audit (IQA) process.
- Managing the CAPA, SCAR and ANR process.
- Revising procedures as required to ensure continued process integration of the Luminex Quality System
- Managing the review and approval of quality Records generated for the Device History Records of products manufactured at LMD
- Conduct the performance of annual product reviews on products manufactured at LMD.
- Supporting Third Party audits and following-up on corrective actions/observations.
- Reviewing design and development records studies and reports.
- Performing training on the quality system as required.
- Participate in related QA related committees as needed. (SRB, Reagent CAPA)
- Equivalent signature level/signing authority in the absence of the QA Manager.
- Other QA related projects that will be assigned from time to time
MINIMUM QUALIFICATIONS:
SPECIFIC KNOWLEDGE & TECHNICAL SKILLS
- Thorough knowledge of regulations (21 CFR 820, CMDR and ISO 13485) and their impact on Tm Bioscience.
- Maintain up-to-date knowledge of corporate procedures and policies.
- Attention to detail.
EDUCATION & EXPERIENCE
- Bachelor degree in related science field and a minimum of 2 years experience in QA
Absolutely no phone calls or walk-ins, please. Mail, e-mail, submit online or fax your résumé and references to:
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Mail
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Email
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Fax
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Luminex Corporation
Attn: Careers
12212 Technology Blvd.
Austin, TX 78727-6115
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opportunities@luminexcorp.com
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Submit your resume online.
Click Here
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Fax: (512) 401-5496
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