SUMMARY

Provide leadership and quality-oriented focus to identify, plan and implement the policies and procedures within the business and, as necessary, with our customers and suppliers, to meet quality objectives.

Ensure compliance with medical device regulatory standards, FDA Quality System Regulation (QSR), ISO 13485:2016 and equivalent-international regulations through the development process and ongoing quality/regulatory compliance in manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Assist in developing a vision for the Quality organization and translate that into operating plans and actions to ensure complete customer satisfaction and financially sound business growth.
Ensure the quality of all products produced for commercial distribution domestically and internationally.
Establish and implement quality plans and systems for new product approval/clearance and ensure ongoing operational and quality compliance.
Establish and complete new product / existing product manufacturing and quality engineering activities (e.g., process risk analyses, process validations, sampling plans, statistical process control (SPC), supplier qualifications, and training compliance).
Work with product development teams and suppliers by identifying and implementing quality process improvements for efficiency and effectiveness, and providing prompt investigation and action for non-conformances in manufacturing.
Propose and maintain timelines for submissions and compliance activities based upon company goals, product development, regulatory strategies and applicable federal and state regulations.
With guidance from management and regulatory leadership, assist with regulatory submissions, including 510(k) and CE Marking, Investigational Device Exemption (IDE), and other applications (i.e. Premarket Approval Applications (PMA)) as applicable.
Provide quality guidance and expertise as a member of the product development team including Design Controls, design and process validation, risk management, sterilization validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
Perform labeling reviews and approvals for quality and regulation compliance.
Establish supplier quality requirements and review supplier purchase orders to verify compliance with requirements. Perform supplier qualification and ongoing monitoring.
Interface with quality representatives from suppliers and customers and develop corrective action plans for effective implementation.
Participate in third party audits (FDA, Notified Body) of the Quality System and assist with providing responses to any observations made during those audits.
Maintain Documentation Control System, including reviewing new documentation or revisions, performing change assessments and 510(k) modification analyses with support from management, coordinating cross-functional team approval, distribution and archiving.
Assist management with ongoing quality improvement initiatives.
Interface with suppliers, distributors and end users of our products to the extent necessary to meet business objectives.
Develop and provide internal training on regulatory and quality.
Stay abreast of current applicable testing and regulatory standards, guidance documents and industry working groups.

QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Strong working knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485:2016 and medical device recognized standards (e.g., sterilization validation).
Experience in completing and filing CE and 510(k) requirements.
Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required.
Must be proficient in the use of personal computers to include word processing, spreadsheets, and databases. Must be exacting in handling detailed information/data.
Strong analytical and statistical skills.
Experience in First- and Second-Party auditing is highly desirable.
Quality Auditor, or a Certified Lead ISO Auditor.

EDUCATION AND/OR EXPERIENCE

A Bachelor’s degree in manufacturing engineering, quality engineering, or related field and 5+ years’ experience in quality assurance is required.

LANGUAGE SKILLS
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and government regulations. Strong written and verbal communication skills. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.

MATHEMATICAL SKILLS
Ability to apply basic mathematical tools and basic statistical analysis. Advanced statistical knowledge preferred.

REASONING ABILITIES
Ability to define problems, collect data, establish facts and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS
Certification in an applicable Quality field (i.e. Certified Quality Engineer, Certified Quality Auditor, or a Certified Lead ISO Auditor) is preferred.