Lead Quality Control Inspector
Company: Integra LifeSciences Corporation
Location: Boston
Posted on: March 28, 2025
Job Description:
Changing lives. Building Careers.Joining us is a chance to do
important work that creates change and shapes the future of
healthcare. Thinking differently is what we do best. To us, change
equals opportunity. Every day, our colleagues are challenging
what's possible and making headway to innovate new treatment
pathways to advance patient outcomes and set new standards of
care.The Lead Quality Control Inspector will be responsible for all
activities performed within the Quality Control Inspection team.
This role also involves performing non-conformance investigations,
identifying root causes, and contributing to the continuous
improvement of processes.Works collaboratively with Manufacturing,
Engineering, Quality Assurance, and other functional experts to
support all daily operational activities. Consults with management
to resolve quality, production, and efficiency problems. Functions
in conjunction with Quality Control Inspection Supervisor and
functional experts on special department projects. Performs the
essential duties and responsibilities as listed in section
below.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job
successfully, an individual must be able to perform each essential
duty satisfactorily.
- Collaborate with Quality Management to ensure all quality
standards are met, including but not limited to ensuring all
quality documentation is properly updated and completed in a timely
manner.
- Conduct inspections of products, processes, and systems to
ensure compliance with quality standards.
- Investigate non-conformances, identifying root causes, and
implementing corrective actions.
- Document and report quality control findings and support the
analysis of data to recommend process improvements.
- Conduct inspection and testing of raw materials, intermediates
and recording of test results.
- Assist as needed in test method validation, implementation, and
execution.
- Train employees in quality standards, KPIs and procedures.
- Support the implementation of new or improved quality control
systems as needed.
- Ensure a working inventory of all department components,
materials and solutions is maintained.
- Perform root cause analysis and implement corrective
actions.
- Serve as a formal resource for colleagues with less
experience.
- Ensure compliance with industry regulations, company policies,
and safety standards during the transition process.
- Ensure database support, report generation and process data
analysis.
- Collaborate with Quality Management in preparing for and
participating in FDA audits, customer audits, etc.
- Ensure work areas and equipment are in a clean and orderly
condition.
- Must be able to work in a team environment, multi-task and
communicate effectively.
- Demonstrate excellent organizational and time management
skills.
- Knowledge of industry standards and regulations related to
quality control.
- Perform other duties as required.DESIRED MINIMUM
QUALIFICATIONS:
- High School Diploma with 5+ years of related work experience is
required in a medical device, pharmaceuticals, Quality/Regulatory
Compliance, or other regulated industry.
- Associate or bachelor's degree preferred.
- Familiarity with application of FDA and/or ISO quality
standards in a government regulated industry.
- Moderate computer competence, including experience with
database and Microsoft Office software to create reports,
spreadsheets, analyze data and prepare presentations.
- Knowledge of QC terms, tools, and methodologies.
- Working knowledge of standard laboratory practices and
safety.
- Ability to follow instructions precisely, recognize deviations,
and recommend corrective action.
- Detail-oriented.
- The employee may be required to periodically lift and/or move
up to 25 pounds.TOOLS AND EQUIPMENT USEDCalipers, rulers,
dataloggers, standard office equipment (i.e. computers, phones,
photocopiers, filing cabinets, other general office equipment).
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Keywords: Integra LifeSciences Corporation, Boston , Lead Quality Control Inspector, Other , Boston, Massachusetts
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