Quality Engineer

Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally write and execute test protocols and reports.

Manager is primarily looking for candidates who have project management skills (document rewrites) AND who are good with statistics for statistical reporting and spreadsheets.

Primary Job Functions:

Provide QA technical and compliance expertise as part of development teams in establishing and assuring product quality objectives. Assure compliance to applicable regulations. Perform quality activities such as audits, procedure development, product release, documentation review and define changes to controlled documents. Provides QA technical and compliance support for exiting products and manufacturing sites related to suppliers, corrective and preventive actions, product/process improvements and training.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1. Responsible for compliance with applicable Corporate and Divisional policies and procedures

2. Must be able to travel domestic and international

3. Plans, executes, reports and follows-up on quality system audits (supplier and internal)

4. Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations

5. Monitors compliance with company policies, procedures and applicable regulatory requirements

6. Participates in decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives

7. Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans

8. Assists in the resolution of project issues by working with team members, project customers, and others as appropriate

9. Assists department and project leaders in developing and reporting appropriate performance and quality metrics

Education:

Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.

Experience:

Auditor certification from an industry recognized organization desired

Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point

Strong written and oral communication skills

Good organizational skills, Good presentation skills

Works well in a team-oriented, cross-functional environment

Ability to handle multiple tasks and operate in a fast-paced environment

3-5 years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing)

To find out more about Real Staffing please visit www.realstaffing.com