QA RA MANAGER MEDICAL DEVICES SLC, UT ***HOT****: Hiring Authorities, Inc.

QA RA MANAGER Medical Device

QUALITY ASSURANCE and REGULATORY AFFAIRS MANAGER.

This position is located in Salt Lake City, UT area. This is an exclusive search for a confidential medical device manufacturing client. THIS IS A TIME CRITICAL POSITION. IT HAS AN ANTICIPATED START DATE IN LATE NOVEMBER OR EARLY DECEMBER APPROXIMATELY.

If you are interested and qualified, please email your resume to Blair@HiringAuthorities.com

Medical device experience is MANDATORY. If you do not know what 13485 or 510K are, you are NOT qualified for this position.

This position offers a competitive salary. The company also offers a full range of benefits.

The salary range of this position is depending on your history and what you can “bring to the table” in terms of skills and experience. QA Managers in SLC with medical device experience generally have a salary range of 75k to 90k. Candidates that are slightly above this range should also send us their resume, as we have other opportunities in QA and RA if you have 13485 experiences.

Below is a sample job description, which should give you a clearer picture of what we are looking for. There may be other duties that are not contained within this sample. Actual job description will be presented to qualified candidates.

QA RA MANAGER

• Lead the Quality efforts and activities of the company.

• Manage and lead a diverse set of projects and personnel with a focus on product and process innovation, quality, safety, and effectiveness.

• Formulate quality plans and budgets for the Company, setting goals and priorities related to Quality efforts.

• Responsible for ensuring that the Quality and Operations organization achieves annual operating plan goals and budget targets.

• Foster close cooperative relationships with all functions in the company. Work with Marketing and Senior Staff to develop new product plans and strategies; with manufacturing and Regulatory Affairs to ensure new products are of high quality and are readily manufacturable.

• Refine and enforce policies with particular emphasis on compliance to the company’s Quality System and external regulatory standards including ISO 13485, FDA regulations.

The Manager, Quality will also provide support to Regulatory Affairs:

• Plan, conduct and assist external quality audits on FDA audits.
• Provide awareness of changes in regulations.
• Complete external quality audits on all 510k applications.
• Responsible for maintaining quality system, including ISO 13485 2003, CMDCAS, and CMDR (Canadian Medical Devices Regulations), Mandatory Problem Reporting (Canada) QSR, CAPA system, quality documents and reporting to top management. Ensures complaints are documented and investigated.
• Responsible for any other quality-related duties as required.

The Manager, Quality Assurance and Regulatory Affairs will also provide support of Operations:

• Support product registrations and notifications.
• Support licensing activities of Plants (State, Federal).
• Support FDA and EPA registrations.

The Quality function in cooperation with Regulatory Affairs will manage Product Safety and Quality Functions:

• Assure Safety support of all current products and product initiatives.
• Draft and review regulatory and safety SOPs.
• Participate in the 510k activities as needed.
• Budget responsibility.

The Manager of Quality Assurance and Regulatory Affairs will ensure the quality functions are efficient, effective, and delivered in accordance with Company policies, procedures, and with applicable laws.

· Responsible for ensuring the Quality functions are well coordinated among related departments.

· Good communication exists and assistance is provided as needed.

· Quality control procedures are appropriate and productive, and corrective actions and suggestions are implemented as needed.

· Department personnel are effective, efficient, and optimally utilized. Good communication exists and support is provided as needed.

· The Company’s professional reputation and service excellence are maintained.

· Achieves QA operational objectives by implementing effective audit program, managing Contractor response adequacy and timeliness; determining system improvements.
Meets QA financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.

· Determines QA strategy by studying product requirements; identifying regulatory concerns; analyzing options; recommending, preparing, and presenting corrective action plans; contributing information and opinion to cross-functional teams; preparing implementation plans and time-lines.

· Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends.

· Protects organization's competitiveness by keeping information confidential.

· Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.

EDUCATION AND/OR EXPERIENCE

BS required. MS or MBA preferred. MBA preferred.

5-10 years progressive quality systems/regulatory leadership experience in medical device manufacturing.

Direct experience in establishing and maintaining corporate procedures as they relate to the FDA QSR Quality System regulations. ISO 9001, ISO 13485, MDD, Medical Device Directive 93/42 EEC, and MHW Ordinances.

Experience in working in a developmental stage engineering environment in creating and documenting prototype devices and providing support through design and manufacturing phases with regards to FDA regulatory requirements, documentation, testing and inspection.

IDEAL QUALIFICATIONS

Licenses/Certificate: ASQ (CMQ/OE, CQE, CQA-Biomed, etc.); RAPS (RACUS, RACEU, and RACCAN); Sigma (Black/Green Belt); AAMI (CBET, CRES, etc.)

Ability to implement design controls with emphasis on the creation of Failure Mode and Effects Analysis (FMEA), design review as well as extensive experience with validation/verification techniques.

You must be able to effectively interact with applicable regulatory agencies at the local and/or bureau level.

Hiring Authorities, Inc. is a recruiting firm specializing in the FDA regulated industries. We place numerous candidates each month at World Class companies. More information on us may be viewed at www.HiringAuthorities.com

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