Quality Assurance and Quality Control Manager

Quality Assurance and Quality Control Manager

 

Company: 

PointCare Technologies Inc. 

Functional Area:

Quality 

Reports To: 

President 

Location:

Position available in:Marlborough, MA USA

Language Requirements:

English

Job Type: 

Regular 

Job Time:

Full-Time

Experience Level: 

High Level, Minimum of 5-7 years experience in diagnostic instrumentation

Required Education: 

Bachelors Degree Science (Medical Technology)  

Special skills: 

Demonstrated ability in Flow Cytometry is preferred.

Required Travel: 

25% at times to locations in Africa, Europe and the US 

 

Company Description: 

At PointCare, we believe that the right of access to good medical care is – or should be – universal, no matter where people live. Creating robust and simple diagnostic technology is an essential part of satisfying this basic right. Our purpose is to apply the most advanced methods to meet the challenge of decentralized diagnostics.  Nothing short of this will work. Join our vision today for global access to good medical care.

 

Company Address:

PointCare Technologies, Inc.

181 Cedar Hill Street

Marlborough, MA 01752

www.pointcare.net



Quality Assurance and Quality Control Manager

 

Purpose of Job:

Prepare, implement, conduct and report on product and process quality programs.  Coordinate the activities and investigations of customer feedback/complaints.  Recommend accept/reject for discrepant product, change orders and product labeling.  Recommend “Stop Shipâ€� actions.  Implement processes to monitor product performance, compliance and reliability.  Interface with project teams for current or new product issues.  Generate, prepare and issue routine data for assigned quality reports.  Participate in design and data reviews.  Participate in vendor audits, internal audits, quality and process improvement projects.  Assist in preparation of quality reports.

The QA/QC Associate provides manufacturing systems expertise and knowledge in support of an instrument or product line.  The incumbent helps to support the necessary processes and procedures that ensure that statistical control is maintained in the measured processes.  The incumbent provides systems-level input in the introduction of new product enhancements.  The incumbent ensures compliance to all FDA, GMP and Quality Policies of PointCare Technologies, Inc.

 

 

Job Responsibilities (include but are not limited to):

 Coordinates research and development input to manufacturing quality specifications.Participates in the analysis, design and development of validation and verification test programs.Reports status and/or results of tests to executive management.Analyzes data from clinical evaluations.Review and revise evaluation protocols submitted from external sites.Assures adherence to company and FDA regulations regarding quality.Adheres to policies and procedures.May be signatory for quality system documentation.Oversees document control.Helps to establish the process controls and required metrics.Provides systems support to technicians and engineers.Ensures that quality records are maintained.Follows standard operating procedures and work instructions.Reviews/approves quality records.

QualificationsBachelor’s Degree in Science/QA or related field EDUCATION: Required: BS with related technical background.EXPERIENCE: Minimum of 5-7 years experience in the Biomedical or  similarly regulated industry, preferably in a Quality Assurance or Validation related position. Preferred Skills/Qualifications: Knowledge of regulatory environment. Excellent oral and written communication skills. Excellent organizational skills. Proven decision-making ability. Proven personnel development ability. Good presentation skills. Skills/Competencies: Basic computer skills. Intermediate knowledge of Microsoft Office software. Other Skills: Comply with company policies and procedures.  Follow safe working practices in the execution of assigned duties. Participate in general site and departmental safety initiatives.  Demonstrate initiative and ability to perform as part of a team.