QA/QC Manager (Taunton)

QA/QC Manager (Taunton)

Vacancy expired!

QR Code Link to This Post

One of our clients in the Taunton area (contract sterilization facility) is looking for a QA/QC Manager. This position will support the Administrative, Manufacturing and Quality departments and its non-specific work activities ensuring smooth product flow throughout the process. You will be cross-trained in all departments.

Salary: $75,000 - $90,000 annually

Duties & Responsibilities:

• Develop, write, prepare and review lab/validation documentation/reports. Must assure timely turnaround of all paperwork.

• Understand and execute validation protocols including inoculation of product, set up of studies (including completion of appropriate paperwork), and analysis of data.

• Provide support and hands-on assistance to the laboratory services of BI testing, bioburden testing and miscellaneous testing such as growth promotion, populations, etc.

• Understand all laboratory tests and assist where needed

• Support all laboratory validations including clean room re-certification, incubators temperature profile validations, etc.

• Assist in housekeeping of labs

• Expand/promote laboratory capabilities

• As a Microbiologist/Biologist, provide leadership and maintain quality programs/checks

Requirements:

• BS required; Masters preferred

• Minimum 3 – 5 years of hands on experience in the medical device industry

• Proven ability to maintain upmost confidentiality is paramount

• Must have a pleasant and professional demeanor

• Problem solving abilities; must be able to identify and provide options for correction

• Must be up-to-date with the various standards and guidelines (USP, AAMI, ISO, GMP’s, etc.)

In addition, you will be asked to provide support to the CEO in the following areas:

• Administrating the directives and programs of the Company

• Sales; originating and negotiating contracts with all clients

• Writing and ensuring implementation of the documentation program

• Originating and developing cycles for various medical devices for sterilization

• Developing protocols to validate internal equipment used in operations as well as multiple client product lines

• Expanding/promoting the laboratory capabilities

• Responsible for interface with various regulatory agencies including client auditors, FDA, EPA/DEP, DHSS, OSHA and ISO.

Location:

Express Employment Professionals

705 Myles Standish Blvd

Suite 1 - 2nd Floor

Taunton, MA 02780

(774) 501-1692