Quality Assurance & Regulatory Manager/Director

Quality Assurance & Regulatory Manager/Director

RA/QA, Medical Device



 

Job Summary:

Responsible for the coordination, control, and continuous improvement of processes and methods necessary to control the quality of purchased or fabricated parts, sub-assemblies, and finished products.  Lead a team focusing on continuous improvement projects using six sigma tools, risk analysis, design control, validations, performing FMEA, and ensuring product adherence to the FDA's QSR regulations for medical device manufacturing.  This involves working closely with Operations and Product Development on new product development teams, and active participation in continuous quality improvement activities.

Essential Duties and Responsibilities:



· Develop and maintain QSR compliant processes which control the quality of parts and product throughout the procurement and production cycle.

· Document results of tests and inspections in DHR or Receiving Inspection History Record.

· Must know, facilitate and implement improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards.

· Actively lead or assist activities in the following areas: Incoming Inspection, 1st Article Inspections, CAR’s (Corrective Action Requests), CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, Quality Audits, DHRs, MDRs, and other associated tasks.

· Work with suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.

· Ensure that the Quality System is in compliance with all Regulatory and Quality System requirements.

· Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc).

· Review and approve inspection plans, routers and product drawings.

· Design gauging and provide technical guidance to assure product complies with engineering drawings.

· Participates in the design process for new products; review and approve designs for quality/reliability requirements.

· Participate in conducting internal/vendor audits.

· Prepare FDA 510k applications and compile/review Technical Files for CE Marking

 

Other duties and responsibilities:

·  Will lead teams as required to maintain and improve all aspects of the Quality System. Will lead focused Quality projects or events as required, to resolve problems or make improvements to specific processes, designs, or product packaging and labeling.

·  Oversee inspections on materials using drawings and necessary inspection tools as required per defined inspection codes and/or inspection checklists.

·  Review vendor supplied data and quality records for conformance and good documentation practices.

 

Qualifications:

·  Demonstrates strong analytical, problem solving skills. 
·  Strong written and verbal communication skills.

·  Detail oriented, good organizational traits.

·  Self motivated, with strong leadership abilities.

·  Candidate must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.

·  Good computer and skills; inclination to adopt technology to maximize efficiency



Education and Experience:

·  Bachelors of Science Degree in a Quality Management, or in an Engineering field with a strong Quality background.

·  Experience in the Medical Device and/or Pharmaceutical Industry with an understanding of the FDA CGMP’s is required.
·  Strong working knowledge of SAP preferred. (Quality Management Module)

·  5 plus years working in a Quality Control / Assurance area.

·  Must be familiar with MRP, SPC, Geometric Dimensioning & Tolerancing and mechanical drawings.

·  Strong knowledge of blueprint reading, statistics, sampling, gauge design, gauging methods, and process control necessary.

·  Experience and knowledge of medical device Quality System Regulations and ISO Standards.



 

If you are an innovative professional who enjoys very stimulating work, this is the role for you! The RA/QA Manager position is an outstanding opportunity to direct and coordinate the company’s product quality and regulatory affairs directives according to government and industry regulations.  As Life Spine’s RA/QA expert, you will spearhead the establishment product approval and quality objectives and policies for the company.

Please send your cover letter, resume, and salary requirements to careers@lifespine.com



This position is being sought after for immediate hire.
Life Spine is an Equal Opportunity Employer.