Quality Manager

Location
94016, Daly City
Posted
Oct 16, 2019
Ref
QM
Required Education
Bachelors Degree
Position Type
Full time

Looking for a self-motivated, highly organized team member who can jump into our Quality Management System (QMS) development and implementation and have immediate, positive impact.

 

Overview:

Regulatory requirements for quality system records, risk management, design control, change control, CAPA, design and process validations, internal audits, and supplier qualification are all familiar terrain for you. You will work closely with internal and external collaborators to oversee our Product Lifecycle Management (PLM) software and will own maintaining our electronic documents of record. You will oversee supplier audits and maintenance of our supplier qualification program. Balancing prioritization of multiple, simultaneous activities to support our growing company comes naturally to you. You will work closely with scientists in assay development and mechanical, electrical and software engineers to support product development. You will be a critical driver in bringing our products through regulatory review and to market.

Primary Responsibilities:

Lead development and implementation of Quality policies and practices.

Manage timelines and resources (internal and external) to meet program goals

Orchestrate and document design reviews, training plans, internal/external audits, etc.

Support Quality activities related to product development, regulatory filings, and commercial manufacturing

Provide reports on QMS activities to Alveo’s management team

Develop team engagement and build company-wide Quality savvy

 

Minimum Qualifications

Bachelor’s degree or equivalent, 

Relevant professional experience in a regulated industry

5 years of roles of increasing responsibility in Quality working on Medical Device products

3 years leadership experience

Experienced in QSR and using PLM softwareDiversity and flexibility to support 

goals in collaboration with different disciplines

Participation in regulatory submissions

Excellent verbal communication skills to work cross-functionally across multiple departments

Clear technical writing skills (English) to develop procedures, specifications, and training

 

Preferred Qualifications

Quality leadership role working on IVD products from research through commercialization at a start-up