Description

Accountable for leading the Quality Assurance department at the Boerne, Texas site. Plans, coordinates, and directs quality assurance activities directly or through delegates to ensure continuous production of products consistent with the Quality Management System with a focus on organizational compliance. Ensures all products manufactured and services provided by the company meet the applicable quality requirements.

Essential Functions, included but not limited to:

Appointed as the local Management Representative.
Direct activities of the quality system to ensure compliance to both national and international requirements.
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.
Regulate document control systems including labels, IFU revisions, operating procedures, etc., and all related documents that create the Quality Management System, meeting ISO, GMP/QSR, and company directives.
Write 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.
Coordinate 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 registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable.
Support audits conducted by regulatory agencies.
Develop and maintain performance of site Quality Assurance 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 ISO 9001, ISO 13485 and MDSAP, to ensure all aspects of the QMS are 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 of 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.
Adhere to current Good Manufacturing Practices(cGMP); Ensure all direct reports comply.
Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

Supervisory Responsibilities:

Directly manage the Quality Assurance personnel at the Boerne site.
Fulfill Manager 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.

Requirements

Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field.
Legally authorized to work in the United States.
Five (5) years quality assurance experience.
Two (2) years quality experience in relation to medical device or In vitro diagnostics devices.
Two (2) years of supervisory experience.
Strong knowledge of various standards and regulations such as ISO 9001, 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.

Preferred Qualifications:

Five (5) years proven quality experience in relation to In vitro diagnostics devices.
Knowledgeable with ERP systems such as ProAlpha, Oracle, SAP and AS400.
Prior manufacturing experience.

Basic Skills and Abilities:

Good computer skills including Microsoft Word, Excel, Outlook.
Detail oriented with a high level of accuracy, efficiency, and accountability.
Excellent organizational skills to meet goals and set priorities.
Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Initiative to offer new innovative ideas and improve processes.
Ability to work independently and as a member of various teams and committees.
Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
Capacity to foster a participative management style advocating a team concept.
Good coaching, mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.