Quality Mgt Systems Specialist
Company: KARL STORZ ENDOSCOPY
Location: Auburn
Posted on: January 27, 2023
Job Description:
We are currently seeking a Quality Management Systems Specialist
at KARL STORZ. In this role you will primarily be responsible for
leading and/or supporting efforts to meet the requirements of
FDA/QSR systems, along with continued company growth. Ensure that
processes are compliant, effective, and efficient. Leads the
department when Quality Manager is absent.
REQUIREMENTS
- Bachelor's Degree Required.
- 5 or more years' experience in a Quality Control, Quality
Assurance, Continuous Improvement, Process Control, or
Manufacturing Engineering is Required.
- Analytical, written/oral communication, PC, and organizational
skills will be essential for successful completion of duties.
- Experience in an FDA and/or ISO regulated Environment or
Medical Devices desirable. Experience with Six Sigma, Kaizen, 5S,
or other improvement methodologies a plus.
- Ability to read blueprints/schematics required. Ability to
write specifications a plus.
- Experience with supplier evaluation and auditing.
RESPONSIBILITIES
- All employees are expected to be knowledgeable about and follow
the Company's Equal Employment and Affirmative Action Policies,
including policies on the rights of individuals with disabilities
and harassment.
- Own various quality systems which includes responsibilities for
writing and revising procedures, ensuring compliance, and
establishing and monitoring performance metrics
- Work to ensure processes are compliant with FDA/QSR and ISO
requirements.
- Monitors quality system performance to compliance with
regulations, standards, and the KARL STORZ quality management
system.
- Identify and lead projects to improve process efficiency and
effectiveness.
- Perform analysis, trending, and reporting of non-conformance,
and complaint data.
- Lead and/or assist with efforts to document processes for
compliance with FDA/QSR and ISO requirements.
- Manages the critical suppliers, develops supplier
relationships, conducts supplier audits, and monitors and reports
supplier performance to management.
- Reports quality management system performance to management
review and takes action items to improve quality management system
performance.
- Monitors and reports on training system to ensure training
requirements are identified and personnel are trained in a timely
manner.
- Must be punctual, able to sustain attendance guidelines, and
work hours as assigned.
- This incumbent will work in a typical office environment. May
need to spend significant amount of time in operational areas.
- May need to lift up to 40 lbs.
- Must be able to use phone and spend lengthy amount of time at
computer creating/searching for information.
- May require frequent travel, up to 25%.
- Position requires good judgment and decision-making
skills.
- Position requires excellent attention to details.
- Lead and participate in cross-departmental meetings.
- Ability to establish strong cross functional relationships
SAFETY:
Must be committed to a high standard of safety and be willing and
able to comply with all safety laws and all the Company's safety
policies and rules. Must be willing to report safety violations and
potential safety violations to appropriate supervisory or
management personnel.
QUALITY:
The incumbent in this position is generally responsible for
following FDA/QSR guidelines as described in the procedures related
to his/her specific job responsibilities.
#LI-AA1
Keywords: KARL STORZ ENDOSCOPY, Worcester , Quality Mgt Systems Specialist, Other , Auburn, Massachusetts
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