Black Star Technology LLC
Senior Quality Control Inspector - Medical Devices
Black Star Technology LLC, Littleton, Massachusetts, us, 01460
About the job Senior Quality Control Inspector - Medical Devices
We are seeking a
Senior Quality Control Inspector
to join our growing team in
Littleton, MA . In this hands-on role, you will perform precise mechanical inspections to ensure our products meet the highest standards of quality and compliance. You will work closely with cross-functional teams, supporting manufacturing and R&D processes while maintaining adherence to
FDA
and
ISO 13485
requirements.
If you have a passion for precision, attention to detail, and experience in
medical device inspection , this is an excellent opportunity to advance your career in a dynamic and collaborative environment.
Key Responsibilities:
Perform
dimensional, visual, and functional inspections
of components, subassemblies, and finished products. Conduct
First Article Inspections (FAI) ,
in-process ,
final , and
RMA
inspections. Maintain and calibrate inspection equipment within the
Quality Control Lab ; assist with internal calibrations. Create and maintain part-specific inspection forms and
quality documentation . Support
R&D projects
and
new product development
with inspection expertise. Interpret
engineering drawings ,
specifications , and
GD&T
to ensure product compliance. Document and process
non-conformances , and assist with root cause investigations. Prepare
inspection records
for internal and external
audits . Collaborate with suppliers for product verification and technical clarification. Participate in
continuous improvement initiatives
to enhance inspection accuracy and efficiency. Qualifications:
Required:
High school diploma or equivalent (Technical degree a plus) 7+ years of Quality Control inspection experience
in a manufacturing environment (medical device preferred) Strong knowledge of
mechanical inspection ,
metrology , and
calibration processes Proficient in reading
engineering drawings
and interpreting
GD&T symbols Skilled in using inspection tools such as
calipers, micrometers, microhite, pin gages, and thread gages Experience with
ERP/MRP systems
and
electronic Quality Management Systems (eQMS) Familiarity with
IPC standards
for inspection Benefits:
Competitive salary based on experience Comprehensive
health, dental, and vision insurance Paid time off (PTO)
and paid holidays 401(k) plan with company match Professional development and
career advancement opportunities
We are seeking a
Senior Quality Control Inspector
to join our growing team in
Littleton, MA . In this hands-on role, you will perform precise mechanical inspections to ensure our products meet the highest standards of quality and compliance. You will work closely with cross-functional teams, supporting manufacturing and R&D processes while maintaining adherence to
FDA
and
ISO 13485
requirements.
If you have a passion for precision, attention to detail, and experience in
medical device inspection , this is an excellent opportunity to advance your career in a dynamic and collaborative environment.
Key Responsibilities:
Perform
dimensional, visual, and functional inspections
of components, subassemblies, and finished products. Conduct
First Article Inspections (FAI) ,
in-process ,
final , and
RMA
inspections. Maintain and calibrate inspection equipment within the
Quality Control Lab ; assist with internal calibrations. Create and maintain part-specific inspection forms and
quality documentation . Support
R&D projects
and
new product development
with inspection expertise. Interpret
engineering drawings ,
specifications , and
GD&T
to ensure product compliance. Document and process
non-conformances , and assist with root cause investigations. Prepare
inspection records
for internal and external
audits . Collaborate with suppliers for product verification and technical clarification. Participate in
continuous improvement initiatives
to enhance inspection accuracy and efficiency. Qualifications:
Required:
High school diploma or equivalent (Technical degree a plus) 7+ years of Quality Control inspection experience
in a manufacturing environment (medical device preferred) Strong knowledge of
mechanical inspection ,
metrology , and
calibration processes Proficient in reading
engineering drawings
and interpreting
GD&T symbols Skilled in using inspection tools such as
calipers, micrometers, microhite, pin gages, and thread gages Experience with
ERP/MRP systems
and
electronic Quality Management Systems (eQMS) Familiarity with
IPC standards
for inspection Benefits:
Competitive salary based on experience Comprehensive
health, dental, and vision insurance Paid time off (PTO)
and paid holidays 401(k) plan with company match Professional development and
career advancement opportunities