What are the responsibilities and job description for the Quality Auditor position at System One?
Quality Auditor
Location: Burlington, MA area
Start Date: ASAP!!
Duration: Direct Hire
Hours: Mon-Fri; 8am-4:30pm
Degree:
- BS degree in chemistry, physics, chemical engineering, biomedical or mechanical engineering
Experience:
- 3-5 yrs. experience in the Med Device field
- Strong Med Device Auditing experience
"MUST HAVES":
- Strong Audit exp. in the Med Device industry
- Mechanical aptitude and/or biologic mindset(Microbiology or chemistry background)
- Exp. with Quality Systems
- Exp. with CAPA
- Exp. with Complaints
- Exp. with Non-Conformities
"Nice to Haves":
- Design control exp. is a plus
Primary Duties/Responsibilities:
Location: Burlington, MA area
Start Date: ASAP!!
Duration: Direct Hire
Hours: Mon-Fri; 8am-4:30pm
Degree:
- BS degree in chemistry, physics, chemical engineering, biomedical or mechanical engineering
Experience:
- 3-5 yrs. experience in the Med Device field
- Strong Med Device Auditing experience
"MUST HAVES":
- Strong Audit exp. in the Med Device industry
- Mechanical aptitude and/or biologic mindset(Microbiology or chemistry background)
- Exp. with Quality Systems
- Exp. with CAPA
- Exp. with Complaints
- Exp. with Non-Conformities
"Nice to Haves":
- Design control exp. is a plus
Primary Duties/Responsibilities:
- Executes day to day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
- Evaluates medical device failures (product complaints) and writes a summary report
- Determines root cause and implements Corrective and Preventative Actions
- Reads and Interpret Standards in biocompatibility, sterilization and mechanical product testing for developing and updating Standard Operating Procedures and Reviewing or Creating Protocols/Reports.
- Evaluates risk in product design and the manufacturing process of medical devices
- Audits the manufacturing process to confirm compliance to procedures used to manufacture medical devices for assembly, packaging, chemistry formulation of solutions, inspections and testing of the medical devices.
- Updates the quality system based on non-conformities found during internal and external audits
- Reviews Non-Conforming Material Reports for plan and disposition
- Analyzes and reports quality system data to the quality and manufacturing team
- Evaluates supplier performance based on data collected at incoming inspection
Salary : $18 - $120
Sales Associate
Laced Quality Garment Company -
Burlington, MA
Driver /Delivery Driver *Work on your own schedule
Quality Talent Group -
Concord, MA
Driver - Flexible Hours, Quick Earnings
Quality Talent Group -
Pinehurst, MA
