At Cytori we foster a work place culture in which our employees are respected and valued so that we may recruit and retain the best people for our innovative, fast-paced, and exciting business.
Cytori is an equal opportunity employer dedicated to diversity and fairness in the work place and invites you to submit your resume.
Manager of Quality Assurance
Report to: None
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
- 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.
- 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
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.
Enjoy time off on us. A balanced work life increases productivity. Cytori offers paid time off including vacation and 11 paid holidays.
Healthy employees mean a healthy work force. We understand that a comprehensive health and wellness program is key to maintaining a healthy and positive staff. Cytori offers complete health coverage including medical, dental, and vision insurance plan options. We also offer flexible spending accounts to help reserve pre-tax dollars for health and dependent care.
Cytori’s insurance plans provide peace of mind. Our benefits program includes life, short term and long term disability insurance plans to replace a portion of your income in the event of injury, illness, or death.
Reaching your retirement and savings goals is simplified through Cytori’s 401(k) Retirement Savings Plan. The plan is a convenient way for our people to save for retirement and meet future financial goals.
Life can become overwhelming at times, but help is just a call or click away with our employee assistance program (E.A.P.). Cytori’s E.A.P. is designed to provide counseling 24/7 for employees and their family members regarding a variety of issues in or outside the home, from financial advice to conflict resolution at no additional cost.