Head of Quality Assurance
Company: Nachman BioMedical
Location: Newport Beach
Posted on: January 15, 2021
Head of Quality Assurance - Robotic Surgical Systems Establish
and lead the QA department at the US operation of an established
medical device company developing and manufacturing innovative
surgical robotics systems that enable more precise and efficient
placement of orthopedic implants. The experienced medical device QA
Manager selected for this key position will have responsibility for
implementing and managing a Quality Management System that complies
with FDA and international regulations. The range of responsibility
includes creating and managing the QMS, and overseeing the Quality
Engineering, Design Control, and inspection staff. The
- Create the site's QMS and obtain ISO 13485 certification.
- Mange the Quality Department, including quality aspects of
Design Control, manufacturing process, and customer
- Serve as subject matter expert for the entire Quality System
(CAPA, Product non- conformance, internal audit, document
management, change control, etc.).
- Assure compliance with regulatory requirements such as 21 CFR
Part 820, ISO 13485 and 14971.
- Lead the quality management review process, present content and
ensure review is adequate to maintain an effective QMS that
satisfies all regulatory requirements.
- Coordinate and conduct external QA audits of critical
- Lead the complaint handling process, facilitate resolution, and
implement effective containment and close-loop
- Establish processes for monitoring the quality of manufactured
product with consistency throughout the manufacturing process, and
make needed corrections and improvements.
- Ensure NPI projects are adequately supported by Quality
Department from inception.
- Prepare and evaluate trends in quality system to monitor
effectiveness, including development of metrics and KPIs for
quality that will drive system wide improvements.
- Lead and support CAPA and QMS continuous improvement projects
by collecting, analyzing and validating quality data. Required
Qualifications and Skills:
- Minimum of a BS in engineering, sciences, or related field 10+
years' experience in medical device Quality Assurance, including
design and manufacturing, with a minimum of 5 years in a QA
- Extensive working knowledge of cGMP/QSRs, 21 CR 820, ISO 13485
and ISO 14971.
- Strong working knowledge of design controls, document controls,
design V&V, supplier selection and management, hazard analysis
techniques, and regulatory approval methods.
- Significant experience incorporating quality into new product
development and introduction.
- Previous experience with ERP systems, electronic document
management systems preferred.
- Excellent teamwork skills with proven ability to collaborate
with cross-functional teamsHighly motivated self-starter needing
- Ability to travel up to 10%, depending on Covid pandemic
Keywords: Nachman BioMedical, Newport Beach , Head of Quality Assurance, Other , Newport Beach, California
Didn't find what you're looking for? Search again!