Director, Quality Management Systems and Quality Engineering AngioScore
THIS JOB HAS EXPIRED AngioScore:
AngioScore?s Scoring Balloon Catheter significantly alters the landscape for treating both peripheral arterial disease and coronary artery disease.
Location and Reporting Relationship:
AngioScore is based in Fremont, California. The position reports to the SVP, Medical, Regulatory & Quality
Provide leadership for Quality Management Systems (QMS) and Quality Engineering (QE) functions including product development, quality operations, and manufacturing operations to ensure continual regulatory compliance, supplier quality improvements and achieve corporate objectives. Manage/lead quality engineering analysis and documentation of investigations relating to product complaints, NCMR, CAPA, and QC test method deviations. Act as principle company resource for statistics-related issues; e.g. sample size methodology, statistical process controls, reliability analysis and control charting.
Major Duties and Responsibilities:
Manage/lead QMS and QE Departments. Hire, train, and supervise department personnel. Provide technical oversight and leadership for all QMS and QE related activities, including team-based and individual development of: quality planning, design and process Failure Modes and Effects Analysis (FMEA), product testing, product verification and validation testing protocols and reports, manufacturing process validation protocols and reports, and software validations. Ensure department personnel are adequately trained and qualified to perform job function; provide cross-functional training among staff members to support and achieve corporate objectives.
QMS department responsibilities include: document control, corporate training, complaint handling, MDR reporting, and internal auditing.
QE department responsibilities include: supplier evaluation, qualification, and monitoring; QA support for new product development and product line extensions; QA support for product, process, and test method validations; and auditing company equipment calibration/maintenance program.
Maintain an effective Quality Management System (QMS) to ensure compliance with regulations and standards. Develop and lead the continual improvement of the QMS based upon the business needs of the company. Direct/manage and continually improve the document control program. Verify the inter-relationships between policy level controlled documents to assure that the set of inter connected processes and controls used by company personnel are properly defined. Educate all employees on QMS systems changes that affect policy level controlled documents. Maintain awareness of current industry practices and adopt these as appropriate. Schedule, coordinate, and chair QMS Management Reviews.
The Director of QMS is the primary company representative with federal and state inspector(s), and other external auditors (e.g. Notified Body and distributors) during company inspections/audits as it relates to the Quality Management System (QMS). Periodically inspect facility to ensure QSR compliance.
Oversee quality system Management Reviews; evaluate processes and take action to continually improve the Quality Management System (QMS). Ensure that adequate corporate resources, including work environment and the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, meet the requirements of applicable international regulations/standards.
Direct/manage and continually improve the complaint handling program. In collaboration with Customer Service, ensure that complaints are documented timely and accurately. Verify complaint records are maintained and closed timely. Supervise the process for complaint investigations, including returned goods evaluations. Maintain and implement post-marketing policies and procedures for vigilance requirements, including Medical Device Reporting; ensure timely completion of regulatory reporting determinations and submit reports timely. Direct the process for identifying potential failures and causes for failures. Ensure systemic product quality issues are identified and pursued through the CAPA program. Maintain complaint log to ensure inspection readiness at all times.
Direct/manage and continually improve the company-wide training program. Foster company awareness of QMS requirements and ensure Training Program is compliant with all applicable regulations. Conduct new employee and annual all employee QMS Awareness training.
Direct the internal auditing program, including verification of the effectiveness of corrective actions. Ensure that internal audits are conducted timely in accordance with the approved schedule.
Apply appropriate statistical techniques to reduce RMA, NCMR, in-process testing, and finished device testing requirements. Collaborate with Manufacturing Operations to document non-conformances, and ensure quality problems are identified and pursued through the NCMR or CAPA program, as needed. Analyze, investigate, communicate, and lead the process of problem resolution within prescribed scope of authority.
Direct the Non-conforming Materials Review (NCMR) Program. In collaboration with Manufacturing Operations, QC, and company suppliers, direct and assure timely reporting, analysis, and resolution of non-conforming material/product incidences. Ensure systemic supplier quality issues are adequately processed and documented through the Supplier Corrective Action Reporting Program.
Direct Statistical Techniques Program; ensure compliance to 21 CFR 820. 250. Ensure all design verifications and validations, including process and manufacturing validations, are performed using valid statistical techniques for verifying the acceptability of process capability and product characteristics.
In collaboration with the Quality Assurance and Quality Control Manager, develop and revise specifications, test methods, sampling plans, and procedures for the QC department. Provide QE analysis and trouble-shooting of QC test method deviations. The Director of QE is the Acting QA/QC Manager, on an as needed basis.
Plan, schedule and complete projects in a manner consistent with company objectives.
The incumbent has the authority to; stop or cease activities within his or her responsible area that does not meet QMS, health or safety requirements.
The incumbent is the Management Representative (Responsible Engineering Manager or Sekinin-Gijutsu-Sha) for the Quality Management System.
BS in life sciences, Engineering or equivalent. Quality Engineering Certification (CQE), documented evidence required.
Minimum ten years quality assurance/engineering experience in the therapeutic Medical Device industry. Minimum of five years supervisory experience required.
In-depth knowledge of ISO13485:2003 and FDA Quality System Regulations (QSR), required. Working knowledge of Japanese MHLW Ministerial Ordinance No. 169 and Canadian Medical Devices Regulations, SOR/98-282 (CMDR). Quality Lead Auditor certificate and/or certified quality auditor (e.g. ASQ-CQA) through recognized quality association or organization and membership to American Society for Quality, preferred.
Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally; must have clear, confident oral presentation skills.
Individual must be able to generate and explain detailed proposals, guidelines, and procedures for Quality requirements.
Individual must have demonstrated effective managerial and organizational skills.
Individual must have the ability to apply concepts such as fractions, percentages, ratios, and proportions statistics, and related, to practical situations.
Analytical and Reading Skills:
Individual must have excellent analytical skills, and the ability to read, analyze, interpret and assist in the creation and refinement of company procedures.
Individual must have the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Individual must be able to analyze and resolve non-routine product issues using independent judgment.
Individual must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
||5055 Brandin Court |
Fremont, CA 94538
THIS JOB HAS EXPIRED