Tasks and Responsibilities:
- Reports on the performance of the Quality System (QS) for Management Review meetings and any need for improvement; prepares agenda and establishes records for Management Review meetings.
- Plans, manages, and controls programs and procedures that maintain an acceptable level of product quality as established by various federal, state, customer, and company requirements, including quality of purchased material, in-process material, and finished goods.
- Provides leadership and guidance in implementing action for quality programs and for controlling quality costs.
- Serves as Management Representative for the QS and represent the Company in all audits.
- Ensures that processes needed for the QMS are established, implemented and maintained.
- Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
- Ensures establishment and maintenance of site regulatory registrations.
- Support, coordinate and oversee site customer-requested, external regulatory, and internal audits.
- Provides oversight and ensure compliance of QS support elements for the site QMS: Internal audits, Training, Document Control, Supplier Quality Management, Complaint Management, CAPA, NC Management, and Calibration Systems
- Reviews and approves of all QS documents.
- Maintains higher level quality system documents including Quality System Manual (QSM), Work Instructions (WI), Standard Operating Procedures (SOP) related to Quality.
- Ensures that processes needed for the quality management system are established, implemented and maintained.
- Manages the internal audit program including planning, scheduling, review and approval of audits.
- Has responsibility for product quality issues (i.e., supplier evaluations and approvals, inspection, test and measurement, nonconforming product, etc.)
- Supports Material Review Board (MRB) activities for nonconforming product.
- Has responsibility for the Corrective and Preventive Action (CAPA) system, complaint handling system, training program, documentation control system, and quality records.
- Supports validation activities and approvals, as needed.
- Provides quality training for personnel as needed.
- Maintains Quality Agreements (as required) with customers
Education and Experience Required:
- 4 year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science or related field
- 5+ years of experience in Quality Assurance and/or Regulatory Affairs
- Auditor certificate or equivalent experience
- 3 years supervisory experience
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated competence using Microsoft Office
- Demonstrate senior leadership abilities with the capacity to accept responsibility and delegate authority.
- Good managerial, analytical, organizational, and communication skills.
- Math and computer literate.
- Understanding of basic statistics.
- Competent knowledge of equipment and manufacturing operations.
- Thorough understanding of Validations (including equipment qualification (IQ/OQ), process validation, test method validation, computer systems and software validations, etc.); understanding of process capability.
- Thorough understanding of medical device quality system standards, specifications, laws, and regulations, i.e., FDA Quality System Regulations (21 CFR Part 820) and Current Good Manufacturing Practices (21 CFR Part 210 & 211), ISO 13485, and other industrial standards as applicable.
- Correctable normal reading distance vision.
- Knowledge of product drawings, specifications as well as measuring and testing devices.
- Comprehensive working knowledge of applicable corporate policies and quality system documentation.
- Ability to maintain a professional and respectful relationship with coworkers and company.
This position will require you to submit to and pass a drug test and/or background check.
EirMed, LLC, will comply with all applicable federal and state laws governing the use of such background checks and drug tests.
We offer stability, competitive salary and benefits, and the opportunity for career growth to the right individual.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law