Job Description

Description

Process owner for the compliance of the design control, change control, validation, and risk management systems. Works on a wide range of quality problems related to Quality Systems and Product Quality. Support maintenance of the Quality Systems.

Essential Functions:

• Expected to lead the on-going audit readiness and interface with external regulatory and audit agencies regarding the design control, change control, validation, and risk management systems.
• Develops, modifies and implements business processes & documentation of the design and development of products and processes for new products, product changes and enhancements by partnering with design and development functions to translate system requirements into robust & consistent practices.
• Drives the compliant execution of the design and development control systems.
• Leads, mentors, and coaches organization on design quality.
• Reviews protocols, reports, studies, and experiments produced for new products, product changes and enhancements.
• Stays current on related ISO/EN/FDA/IVDD and other Product Development related regulatory requirements and appraises the Product Development group as appropriate.
• Supports prototype and pilot production of new products, product changes, and enhancements along with test methods development and validation.
• Develops, modifies and implements business processes & documentation for the change control system.
• Manages the change control systems.
• Evaluates change orders to for compliance, accuracy and completeness.
• Create and manage the Facility Master Validation Plan.
• Reviews and approves validation documentation.
• Provides guidance on how to create, execute and complete validation documents.
• Helps to develop and manage product and process risk control measures (i.e. dFMEA, FMEA, control plans, risk evaluation).
• Creates and applies policies and procedures for identifying, analyzing risk throughout the product life cycle.
• Assembles, analyzes, and presents metrics in support of trending and Management Review.
• Provide quality support to engineering and manufacturing for troubleshooting and resolving technical problems.
• Other duties as assigned; as emerging growth company it may be required to assist in other areas other than the area of specialty.

Qualifications

• Bachelor's degree in Engineering, Microbiology, Biology, Chemistry, Quality, or related field. 
• Minimum of 7 years of experience in quality systems and process improvements during the development, manufacture, and commercialization of in-vitro diagnostic platforms.
• Experience managing a team.

Knowledge, Skills and Abilities:

• Strong knowledge of the FDA QSR’s and ISO 13485:2012, specifically, Design Control, validation, and risk management.
• Prior experience in the Medical Device and/or IVD industry with early stage (Start–up) company experience highly preferred.
• Experience working medical device and/or IVD industry with software-driven electro mechanical medical devices platforms, manufacturing equipment, and processes qualifications (IQ/OQ/PQ) strongly desired.
• Design control experience with 510k and/or PMA products
• Proficient in cross-section of validation methodology & evaluation of criteria
• Advanced knowledge of statistical principals of DOE, ANOVA, Cpk, etc.
• Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
• Critical attributes and skills include creatively initiative, detail oriented, ability to prioritize and negotiate priorities, hands on approach, and also multi-tasking.
• Analytical / problem solving skills with a demonstrated ability to collect, summarize and report technical information.
• Must possess excellent written and verbal communication skills.
•  Self-starter, and motivated individual who works independently