Quality Assurance (QA) Manager

MicroPhage currently has an opening for the position of QA Manager. In this position, the successful candidate will be the primary person responsible for establishing and managing all QA functions for the company, including document control, internal and external auditing, and providing an effective and QA system compliant to FDA QSR and ISO 13485 for a specifications developer. As an early stage company, the QA Manager will be asked to build the company's QA system andprocesses essentially from scratch. Highly motivated and goal driven individuals are encouraged to apply.

All applicants are asked to carefully read the posting's job description and requirements carefully before applying. Applications will be taken and considered on a rolling basis until the position is filled. This is an immediate placement opportunity. National candidates are welcome.

Principal Duties and Responsibilities:
1) Writes and maintains MicroPhage Quality Policies.

2) Leads in the development, revision, application, maintenance, validation and review of quality standards, documents, investigations and follow up corrective actions to assure compliance with MicroPhage Quality Policies.

3) Implements, maintains, and/or improves quality systems to meet or exceed regulatory compliance.

4) Designs, develops, implements and evaluates educational and training programs for Board and staff.

5) Maintains current knowledge of cGMP/QSR, ISO, and other related regulations and offers training as appropriate.

6) Works closely with MicroPhage Regulatory, Marketing, Research, & Product Development groups.

7) Leads the Design Control process.

8) Interacts with external partners, including assay, device, and instrument developers; and oem manufacturers, to integrate external and internal quality systems to meet FDA and ISO requirements.

Job Specification (minimal requirements):
1) At least 5 years in a Quality Assurance Associate, Specialist, and/or Manager Role.

2) Experience in creating and implementing a quality system in an IVD or Medical Devices Company.

3) At least 3 years working in Medical Devices or In-vitro Diagnostics.

4) Life Science degree (BS) or equivalent.

5) Attention to detail and accuracy, good organizational and planning skills.

6) Demonstrated ability to meet deadlines.

7) Solid oral and written communication skills.

8) Motivation to help build a highly innovative start-up company.

9) Certification / membership in RAPS and/or ASQ helpful.

Working conditions:
Normal office environment with an adjoining BSL2 microbiology laboratory working with a variety of infectious disease agents.

Applicants are requested to apply by email to jobs@micro-phage.com. Please include the following:

- Current resume. Please submit as one of the following file types: txt, .rtf., .doc. or .pdf

- Reference list (No references will be contacted until confirmed with the candidate). Minimum requirement is 2 professional or educational references for ALL MicroPhage positions.

- Cover letter. Preferably, this is included as the text of your email, and not as an attachment. Please reference the opening in the subject line of your email and/or in your cover letter.

- Salary requirements. Please include a minimum salary requirement with your application. This can be provided within the cover letter.

Applications failing to provide these minimum elements may not be considered. Applications are reviewed on a rolling basis until the position is filled. Due to the high volume of resumes we receive, only applicants whom MicroPhage is interesting considering further will be contacted by the appropriate department manager. All applications will be kept in strictest confidence by MicroPhage.

Please, no calls or faxes. Thank you.