This is a highly responsible, independent and supervisory position responsible for managing all aspects of the site Quality Management System and quality improvement process. This position requires strong medical device manufacturing, customer relations, organizational, and leadership skills as well as a strong working knowledge of quality control measures, quality control programs and regulatory compliance requirements in an ISO 13485 and FDA’s 21CFR820 environment.
- Responsible managing, coaching, developing, training and evaluating performance of Quality Inspectors – Incoming, In-Process, Final. Metrologists and Quality Engineers
- Maintains a robust Quality Management System that meets all FDA’s 21CFR820 and ISO 13485 requirements.
- Prepare and conduct site Management Reviews and participate in Corporate Management Reviews
- Ensure customer satisfaction with product quality and meeting compliance requirements.
- Implements changes in the process/procedures and develop new SOPs as needed to improve product quality with meeting all regulatory compliance requirements.
- Manage site internal audit, CARs and CAPAs program.
- Responsible reviewing sites related Customer Quality Agreements.
- Conduct weekly/monthly/quarterly internal and customer meetings as needed.
- Manage MRB. Receive and provide communications and related materials / reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data and other information required by the customer in regard to quality.
- Receives, interprets and implements corrective action procedures as required by the customer in regard to product quality.
- Support Operation to maintain Cleanroom BioBurden requirements.
- Experience performing and managing Process Validation, including IQ, OQ, PQ and PPQ
- Experience performing PPAP
- Knowledge and Experience in 6 Sigma Quality including Statistical Process Control and Process Capabilities studies.
- Experience creating and maintaining Medical Device manufacturing culture throughout the site with emphases on Quality and compliance
- Experience in training employees on cGMP, ISO 13485 & 21CFR 820 elements, Problem Solving Tolls including 5 Whys, Fish-bone Diagram, 8D and others. Knowledge of 21CFR Part 11, 210 & 211
- Perform various computer related tasks and programs including: Excel, PowerPoint, Word, Mini-Tab, and/or others related tools.
- Familiarity with GDT (Geometric Dimension & Tolerance) procedures and requirements.
- Uses nonconformance data to determine trends and any necessary changes to eliminate rejections and/or procedural problems.
- BS in an applicable technical field is desirable with 8+ years of quality management experience.
- Master’s degree and ASQ Certifications is a plus.
- Light Work – Exerting up to 20 pounds of force occasionally, and / or up to 10 pounds of force frequently, and / or lift, carry, push, pull or otherwise move objects. If the use of arm and / or leg controls requires exertion of force greater than sedentary work and worker sits most of the time, the job is light work.
- Worker is required to have close visual acuity to perform activities such as:
- Preparing and analyzing data and figures
- Viewing a computer screen
- Extensive reading
- Visual inspection involving small defects, small parts, and/or operating machines (including inspection)
- Using measurement devices
- Assembly or fabrication of parts at distance close to the eyes
- Worker is not exposed to adverse environmental conditions (as in typical office or administrative work)
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.