Job Description
GENERAL DESCRIPTION
This is a highly responsible, independent and managerial position responsible for all aspects of the quality systems process. This position requires strong medical manufacturing, customer relations, organizational, and leadership skills as well as a working knowledge of quality control measures and quality control programs in an FDA medical devices and ISO 13485 environment.
Position Description/Responsibilities: - Position reports to Sr. Director Quality Assurance and Regulatory Affairs
- Provide strategic leadership on all regulatory affairs and quality assurance programs and policies; strengthen and continually improve company-wide level of internal and external quality.
- Lead quality assurance department in the design, provision, and maintenance of systems for document and data change control, training, corrective and preventive action, discrepancy handling, and complaint handling.
- Provide consultation to all departments on application of quality and regulatory requirements.
- Develop and maintain quality system procedures for quality and regulatory department responsibilities.
- Lead quality assurance and regulatory affairs functional review and approval of quality system documentation.
- Manage quality engineering support function; indirect support to quality inspection teams who report to quality engineering.
- Work in a close, collaborative fashion with management in the pursuit of adherence to documented processes and the development of key performance indicators.
- Interact with customers and suppliers on all quality matters while building and maintaining strong relationships.
- Directs the selection, training, and development of personnel within the limits of company administration policy.
Essential Functions: - Coach, mentor, develop, direct, train, and evaluate the work of quality improvement personnel.
- Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
- Ensure customer satisfaction with product quality.
- Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires.
- Receive, interpret, and implement corrective action procedures for product quality that the customer requires.
- Implement changes in the process/procedures requirements to improve product quality.
- Oversee the internal/external audits and CAPA programs.
Skills: - Possesses written and oral communications sufficient to be an effective, persuasive speaker and negotiator; write editorials, journal articles, speeches, manuals, and critiques; and read scientific journals, abstracts, financial reports, and legal documents.
- Performs advanced mathematical calculations which involve application of theorems, functions, and fundamental concepts in advanced calculus, modern algebra, and statistics.
- Applies principles of rational systems to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Interprets a variety of instructions furnished in written, oral, diagrammatic, or schedule form.
- Performs basic computer operations (cc mail, record keeping, and routine database activity, etc.) and utilizes advanced features of software packages (word processing, spreadsheet, graphics, etc.)
- Knowledgeable of quality systems, SPC, statistics, GMP, GLP.
- Possesses strong people management skills (counseling, coaching, evaluating, directing).
Qualifications: - Bachelor's degree in Engineering or applied science (BSME, BSEE or BS Physics preferred) with minimum of ten years' related experience in reliability/quality field, preferably in the medical device industry.
- ASQC certification a plus.
- At least five years of service in a quality management position.
- "Critical" device experience is a plus.
- Must have aptitude to develop a functional and technical understanding of products to ensure that manufacturing and inspection processes are adequate to ensure appropriate product performance.
Physical Requirements: - Light physical activity performing non-strenuous day-to-day activities of an administrative nature. Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing. Manual dexterity sufficient to reach and handle items. Requires minimal overnight travel (up to 10%) by land and air. Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e. visualize objects of multiple dimensions), and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.). This position normally works in a well-lighted, air-conditioned, indoor office setting with adequate ventilation.
We offer market competitive compensation. Potential salary range for this role is $160,000-$180,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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