Job Type

Full-time
Description
Accountable for leading the Quality Assurance at the South Bend, Indiana site. Plans, coordinates, and directs quality assurance and regulatory activities directly or through delegates to ensure continuous production of products consistent with the Quality Management System and Regulatory requirements with a focus on organizational compliance. Ensures all products manufactured and services provided by the company meet the applicable quality and regulatory requirements.
Essential Functions, included but not limited to: Appointed as the local Management Representative. Direct activities of the quality system to ensure regulatory compliance to both national and international requirements. Communicate with various regulatory and government agencies including but not limited to, Certification/Notified Body, Food and Drug Administration (FDA),), Occupational and Safety Health Administration (OSHA), Department of Transportation (DOT), Department of Public Safety (DPS), Environmental Protection Agency (EPA), Health Canada (HC), European Commission Health and Consumers (SANCO), and other international regulatory and government agencies as applicable. Ensure compliance of products in accordance with country specific requirements to the relevant regulatory requirements. Support regulatory, business and product registration and external affairs activities. Monitor new or revised applicable regulatory requirements. Under the direction of Global Head of Regulatory Affairs, plan and implement new or revised applicable regulatory requirements. Under the direction of the Global Head of Regulatory Affairs assumes the responsibility for maintaining the appropriate licensing of products for domestic markets and facilitate registration materials/documents to support distributors in international markets. Provide regulatory advice and strategies on development of new products or modifications of existing products following implemented procedures, policies and regulatory requirements. Prepare and maintain Technical Documentation (Master Device Records, etc) in accordance with country specific requirements (i.e. US - 510k. EU - IVDR, etc). Submit applications and notifications for market access (i.e. US - 510(k), PMA, etc, EU - IVDR, etc). Provide regulatory support for sales, marketing activities and serve as the regulatory interface with distributors. Support creation and/or reviews of product information in relation to IFUs, labelling, sales and marketing literature. Support the administration of the Supplier Quality Management process. Manage the Supplier program to include the selection, evaluation and ultimate approval of new suppliers. Monitor the performance of suppliers. Conduct training in current Good Manufacturing Practice (cGMP), International Organization for Standardization (ISO) standards, QMS and applicable regulations. Direct product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian and European authorities. Prepare and coordinate issuing of Technical Bulletins or Advisories. Maintain regulatory registrations and licensing with applicable country requirements (i.e. FDA establishment registration and listing, Canada licenses, etc.). Regulate document control systems including labeling, IFU revisions, operating procedures, etc., and all related documents that create the Quality Management System, meeting ISO, GMP/QSR, and company directives. Write, review and update standard operating procedures (SOPs). Oversee of the upkeep of the training program database. Conduct the annual review of the Quality System and cGMP training. Monitor the customer complaint handling process through review and approval of completed complaint investigations. Administer Corrective and Preventative Actions (CAPAs) and non-conformance activities. Review and release finished goods; may review and release in-process goods (IPG) in the absence of the Quality Control Manager. Review stability test results. Create and maintain the annual internal audit schedule. Ensure internal auditors are trained. Coordinate and serve as point of contact for audits conducted by regulatory agencies, registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable. Develop and maintain performance of site Quality Assurance and Regulatory staff utilizing common practices, quality methodologies, processes and tools to ensure consistent and effective quality product outcomes. Lead, maintain, and improve the QMS in line with 21 CFR 820, ISO 13485, MDSAP, to ensure all aspects of the QMS is understood, implemented and maintained by staff. Establish and maintain key performance indicators (KPIs) to gauge overall effectiveness and business impacts of the organization. Ensure Management Review of the QMS is completed and documented to reflect the status if the QMS effectiveness and resulting improvements. Provide leadership and mentorship in non-conformance management and CAPA processes, by ensuring quality investigations are robust, timely and conducted and documented in accordance with company requirements. Implement effect validation strategies in support of continuous improvement with established and evolving regulatory and company requirements. Identify and implement continuous improvement strategies on multiple axes, including but not limited to process, tools, methodologies, and functional competencies. Interact with all company personnel in coordination of quality and regulatory activities and sound business practices in compliance with Quality Policy and Directives. Ensure compliance to safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
Non-Essential Functions: Assist Production as needed in areas where training requirements have been completed. Perform other duties as assigned.
Supervisory Responsibilities: Directly manages the Quality Assurance personnel. Carry 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.
Travel: Able and willing to travel to other sites.
Qualifications Guidelines: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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.
Requirements
Required Qualifications and Skills:
Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field. [DM1] [RP2] [DM3]
Authorized to work in the United States.
5 years quality and regulatory experience in relation to medical device or In vitro diagnostics devices.
Minimum of two years of supervisory experience.
Strong knowledge of various standards and regulations such as ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 665/2022), the Canadian Medical Devices Regulations, and any specific requirements of the medical device regulatory authorities participating in the MDSAP program.
Knowledge of other applicable country regulatory requirements such as the EU IVDD/IVDR and the UK MDR, etc.
Ability to master internal document software (ETQ) and ERP systems.
Strong Root Cause Analysis skills (5 whys, Fishbone Diagrams, etc).
Must be detail oriented and possess strong organizational skills.
Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
Possess the initiative to offer new innovative ideas and improve processes.
Ability to work independently and as a member of various teams and committees.
Capacity to foster a participative management style advocating a team concept.
Excellent coaching, mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Projects a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude while complying with company policies and procedures.
Good computer skills including Microsoft Word, Excel, Outlook.
Desired Qualifications and Skills:
Ten (10) years proven quality and regulatory experience in relation to In vitro diagnostics devices.
Reasoning Abilities:
Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects.
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.
Language Skills:
Good written and oral communication skills; ability to read, write, speak, and understand the English language; ability to communicate effectively, internally, and externally at all levels.
Ability to read, analyze, and interpret general business periodicals, professional scientific and technical journals, technical procedures, financial reports, legal documents, and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Exceptional interpersonal and leadership skills; ability to communicate effectively, internally, and externally at all levels and diverse personalities.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Outstanding communication and presentation skills, both written and oral, to express technical and nontechnical concepts clearly and concisely; Effectively present information to top management, public groups, and/or boards of directors.
Mathematical Skills:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Physical Activities and Demand:
Able to wear personal protective equipment (PPE), such as face masks, gloves, hairnet, etc.
Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
Stationary position sitting for long periods of time while utilizing standard office tools.
Often moving from place to place within the building.
Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
Frequently lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, and rarely lift and/or move up to 50 pounds.
Occasionally reaching for items above and below desk level.
Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl; and smell.
Visual Acuity:
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Use of computer monitor for prolonged periods.
Environment Conditions:
Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
Noise level in the work environment is moderate.
Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
Some exposure to hazards or physical risks, which require following basic safety precautions.
Training Requirements:
To be trained according to all job related standard operating procedures, Quality System Regulations (cGMP, ISO) as well as all other regulatory & safety requirements.