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Manager Quality Assurance

Company: LoremCytori USA, Inc.
Location: San Diego
Posted on: November 22, 2021

Job Description:

Position Title: Manager of Quality Assurance

Department Name: Quality Assurance

Position Summary

Maintain and continue to improve Medical Device Quality Systems and assure continued compliance with FDA GMP / QSR regulations along with European standards to include ISO 13485 and MDR EU 2017/746

Essential Duties and Responsibilities

Assure manufacturing is performed and documented to GMP requirements; US FDA Quality System Regulation, MDR EU 2017/746 and ISO 13485.

Assure Design Control Documentation complies with appropriate regulations (QSR, GMP, ISO, Etc.).

Assist in the oversight of Quality Engineering to assure Design Control Documentation complies with appropriate regulations (QSR, GMP, ISO, Etc.).

Perform QSR activities as well as lead Quality group to complete those activities (CAPA, complaints, audits, training, labeling, etc.)

Perform document Control to include Change Order System, Label Control, Quality Records (LHR, NCMR, Service Records, etc.) and associated Archived Records.

Oversight of Quality Control Activities: Incoming and In-process inspections, Environmental Monitoring, storage, shipping and distribution records, PM records, and SPC (statistical process controls).

Maintain Quality Assurance Program: calibrations, training, internal and external audits, vendor qualifications, Risk Management per ISO 14971, CAPA, complaints, MDR and Vigilance Systems, and supplier ratings.

Manage and schedule activities with all personnel in QA and QC groups and assure projects are completed in timely manner

Prepare for and Lead audits from external regulatory authorities to include FDA investigators, notified bodies and State and local regulatory authorities (California FDB) during on-site audits.

Supervisory Responsibilities

Direct Reports: None

Position Requirements

Education and Experience:

A Bachelors degree in Engineering, Bioengineering, or Life Sciences required and a MSc / MBA preferred. Electromechanical device experience desirable, 5+ years of experience interfacing with FDA investigators and/or ISO Auditors during on-site audits. 5+ years of experience with managing personnel desirable. Requires specific experience in performing and managing of Quality Systems in conformance with FDA Quality System Regulation (cGMP) and ISO 13485. Experience with EU MDR 2017/745 highly desirable. Sterile product experience desirable (steam, e-beam, ETO, gamma, eBeam) and principals of statistical process control, and statistical Quality Control preferred.

Skills - Technical

Detail oriented and computer literate in PC MS word processing, Excel spreadsheets, and databases.

Laboratory experience in biomedical environment is desirable.

Skills - General

Be a self-motivated, customer-oriented person with excellent communication skills

Work professionally with colleagues and be a team player; maintain flexibility with work projects

Complete work in a timely, accurate and thorough manner

Think and work both tactically and strategically to provide operational needs to Cytori's business

Ability to read, write and analyze complex documents

Respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, colleagues and outside constituents

Strong problem-solving, judgment and decision making skills are required

Certifications, Licenses, Registrations

Work Environment

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The work environment and physical demands described are representative of those required by an employee to perform the essential functions of this job with or without reasonable accommodations.

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This document is intended to describe the general content and to identify essential functions and requirements to perform this job. It is not an exhaustive statement of duties, responsibilities or requirements. Cytori (the "Company") complies with all laws pertaining to accommodation of disabled individuals, and considers reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential job functions. Employment with the Company is "at-will," meaning that either the Company or an employee may terminate the employment relationship at any time, with or without cause, notice, reason or stated justification.

Manager of Quality Assurance 11/02/2021

Keywords: LoremCytori USA, Inc., San Diego , Manager Quality Assurance, Executive , San Diego, California

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