This listing was posted on The Resumator.
Quality Director
Location:
Fenton, MO
Description:
As the Director of Quality Assurance with this rapidly growing manufacturer of innovative orthopedic implants and instruments, you will be responsible for FDA and ISO Quality System compliance activities (CAPA Administration, Product Complaints, Failure Investigations, Quality Audits, Supplier Management, Change Control Administration, Process and S/W Validation), and leading process improvement initiatives. You will manage various quality system activities as the Quality Assurance Director, providing guidance on regulatory compliance strategy to meet US and international requirements, as well as the development and maintenance of documents to demonstrate compliance to regulatory requirements. This role will serve as an alternate to the site Management Representative as defined in US FDA and international standards.Principal Duties and Responsibilities (Essential Functions): To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Advises company personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments. • Develop and maintain all necessary QMS procedures, instructions, and forms to implement ISO and US FDA regulatory requirements. • Coordinates with upper management, other departments, customers, or external supplier partners to achieve quality objectives. • Reviews regulatory publications to keep apprised of new regulatory developments. • Work with manufacturing to evaluate process improvements for product reliability issues and to improve overall reliability and quality of products. • Owner of the Supplier Management Program. Work with contract manufacturers and suppliers to improve quality through risk-based classification, pre-qualification reviews, on-going oversight and audits, implementation of process changes and other procedures. • Perform and coordinate internal and external quality system audits. • Assure manufacturing processes are conducted in compliance with the and ensure validation and testing protocols are robust to ensure FDA, ISO and other regulatory requirements are met. • Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in identification and resolution of issues in accordance with Company Quality Objectives. Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions. • Assure control and proper disposition of nonconforming products and corrective actions. • Assure thorough investigation and timely completion of all customer complaints. • Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions. Qualifications & Skills:Minimum Requirements • MUST HAVE a minimum of 3-5 years of experience overseeing the quality management system in an FDA regulated environment. • MUST HAVE experience in determining the testing requirements for biocompatibility, mechanical and other performance tests related to implantable devices • Working knowledge of FDA medical device regulations, guidance documents, recognized consensus standards and developing SOPs, work instructions and other supporting documents to address those requirements. • Demonstrated working knowledge and a history of successfully implementing quality system elements, including, but not limited to: CAPAs, product complaints, design controls, quality system audits, document change controls, employee training, process and software validation. • Ability to exercise independent judgement within defined procedures and practices to determine appropriate action. • Ability to provide guidance and training to company peers • Ability to travel domestically (~10%) to conduct periodic supplier audits • Bachelor’s degree in science, engineering or technical field • Working knowledge of FDA medical device regulations, guidance documents, international standards (ISO 13485, 14971, 17025) Desired Skills • Ability to manage multiple projects simultaneously • Excellent written and verbal communication skills • Excellent organizational skills • MS Office Suite (Word, Excel, Project, Access, PowerPoint, Visio) • Statistical S/W (MiniTab, JMP or equivalent) • RAC Supervisory Responsibilities: Manages subordinate supervisors who supervise employees in the Quality Department. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Work Environment & Physical Demands: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. Noise is moderate.While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.Powered by JazzHR
Company:
Sim Surgical
Posted:
July 1 on The Resumator
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to The Resumator
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Quality Director
Quality Director is a Executive Director Job at Sim Surgical located in Fenton MO. Find other listings like Quality Director by searching Oodle for Executive Director Jobs.
Quality Director is a Executive Director Job at Sim Surgical located in Fenton MO. Find other listings like Quality Director by searching Oodle for Executive Director Jobs.