Quality Programs Manager

QualificationsUS Citizen Masters Degree or Higher in a Technical Field (Preferably Engineering) 2-5 years Relevant Experience including: Internal and/or External (supplier) Auditing ISO 9000, ISO 9001 or ISO13485 compliance FDA and MDD compliance Quality Assurance, Quality Systems, Compliance and/or Quality Engineering Statistical Analysis

 

Job Responsibilities

1.  Quality Assurance and Quality Control functions at the Buffalo facility.

2.  Responsible for compliance with United States, Canadian, European and Japanese regulatory guidelines including but not limited to cGMP, ISO 13485:2003, CE Marking, Health Canada and European Pharmacopeia.

3.  Training of the Buffalo facility on quality matters and statistical controls.

4.  Creation and Implementation of necessary Quality Procedures and Policies

5.  Managing complaint investigation, reporting maintenance of complaint files, MDR reporting, and CAPA trend analysis.

6.  Preparing/reviewing Quality sections for regulatory filings in a timely manner including NDA, ANDA, ANADA, and 510(k).

7.  UL/CSA product registration and/or CE markings where appropriate.

8.  Lead QC Validation efforts including automated testing and software validation.

9.  Internal and vendor audit functions (moderate travel required).

 

Compensation

1.  $72,000

2.  Incentives based on the completion of project milestones

3. Relocation stipend, if necessary.