Medical Device Designer & Contract Manufacturer of single use instruments and disposables

  • Locations in Rochester, NH & Tijuana, Mexico
  • +1 (603) 332-8900

Document Control

Growing contract manufacturer for single use, disposable medical devices is looking for a dependable individual to join our team.  The Document Control candidate should be a self-driven team player who has strong organizational and communication skills.

Position Description: Document Control

Reports to: Quality Assurance Manager

Direct Reports: As Assigned

Responsibilities:

  • Assign PDN numbers, maintain official documents – including master lists, logs, and manuals – and controlled copies per associated procedures.

  • Check ECN documents for proper completion, assign ECN number, and forward to appropriate personnel for review.

  • Ensure that documents are updated, filed, and distributed after ECN approval.

  • Ensure that obsolete documents are stamped and filed or scrapped after ECN approval.

  • Issue reference documents as needed.

  • Maintain Device Master Records (as required).

  • Assist in maintaining traceability of products.

  • Applicable responsibilities as defined in SOP 20-02

  • Other duties as assigned.

Document Control personnel have the authority to perform the following tasks but are not required to do so:

  • Initiate Assembly/Lot History Records for production scheduling.

  • Assign finished product lots numbers.

  • Assign CAR numbers.

Document Control personnel are to be familiar with the following guidelines and procedures, as well as any related forms.

  • Phase 2’s Quality Policy

  • Phase 2’s Quality Manual

  • Phase 2’s Assembly, Inspection, and Test Procedures

  • Phase 2’s Assembly/Lot History Records

  • Phase 2’s Standard Operating Procedures

 

 

 

 

 

Candidates can submit resumes to This email address is being protected from spambots. You need JavaScript enabled to view it..

Competitive benefits offered; however, Phase 2 Medical does not offer relocation packages.

Unsolicited resumes from non-contracted recruiters will not be eligible for fees.

 

Locations

Product Development & US Manufacturing

88 Airport Drive
Rochester, NH 03867

+1 (603) 332-8900


Mexico Manufacturing

Andador Vecinal No 14301
Tijuana, BC CP22330

+1 (664) 231-3844