Makro Scientific: Life to Life for Better Life.

Makro Scientific: Staffing Specialist in Clinical and Scientific.

Job Order ID: LIB- 26343.
Job Title: Quality Assurance Director.
Location: Portsmouth, NH.
Job Type: Fulltime Permanent.

Job Description:

• The Director, Quality Assurance (QA), has the responsibility and authority for directing the organization's Quality Assurance, Quality Services, Quality Engineering and Compliance functions in assuring quality systems, processes and products meet or exceed quality, reliability, and regulatory expectations.
• This position is responsible for assuring the quality operations and products distributed by the company are in compliance with applicable State, Federal and International medical device regulatory requirements and quality standards.
• This position includes direction of QA, Quality Engineering, Quality Services, Quality Systems, Customer Loyalty, and Compliance personnel.
• The Director, QA, is responsible implementing both Surgical Technologies division wide and Advanced Quality strategy, goals and objectives to ensure the overall performance meets or exceeds the expectations while ensuring client activities are aligned to support client and ST division goals and objectives.

Position Responsibilities:

• Authorized and serves as client’s Management Representative as defined by the FDA QSR (21CFR, part 820), and ISO 13485.
• As the Management Representative, manages, schedules and reports on performance of the quality management system to executive management.
• Authorized Responsible Quality Manager for the client facility as defined by Japanese MHLW Ministerial Ordinance No. 169.
• Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.
• Maintains all QA files including all quality records, design history files and external standards assuring that the information is current and accurate.
• Monitors compliance of CAPA, MRB, Internal Audits, Supplier Audits and Complaint Handling.
• Supports ST Compliance activities by coordinating and managing Internal and External Audit functions, including any associated corrective actions.
• Assists with all ST product lot releases and maintains all lot release documentation.
• Provides leadership and mentoring in advanced Quality Assurance disciplines, including, but not limited to, Structured Problem Solving, Six Sigma, PDCA, etc., as directed or necessary.
• Provides communication to Executive Management regarding the status of the System and directs the process for continual quality system improvement.
• Directs Quality, Audit and Corrective Action/Preventive Action activities.

Basic Qualifications:

• Bachelor's or Master's degree in engineering, quality assurance, or an area of life sciences. Advanced degree strongly preferred.
• Minimum of 5 years leadership experience in QA, CAPA, MDR & Vigilance Reporting, Regulatory submissions, and laboratory sciences.
• CQE, CQA or other professional certification desired.
• Minimum of ten years experience with a bachelor's degree or seven years of experience with a master's degree.
• Ten years experience in medical device quality assurance.
• Lean sigma, six sigma and/or other quality tools knowledge and experience. Able to lead projects and demonstrates competency utilizing these tools.

Candidate Must Have:

• 10+ to 15 years of experience.

Location: Portsmouth, NH.
Job Type: Fulltime Permanent.

Contact: Ismail

The best telephone number to reach me is 973-481-0100 Ext: 3044. OR Fax: 973-481-1020 I appreciate if you forward your updated word formatted resume at /ismail.bepari@makrotech.com for review before we speak.

For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005 or E-mail your resume at recruiter@makrotech.com. We shall be happy to help you.