In Process Final Inspector

HireTalent

  • Marlborough, MA
  • 10 days ago
  • Remote
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    Skills

    • Agile Programming Methodologiesunmatched
    • Calibrationunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corporate Policiesunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Documentation Reviewunmatched
    • Documentation Standardsunmatched
    • Engineering Drawingunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Interpersonal Skillsunmatched
    • Investigative Reportsunmatched
    • Leadershipunmatched
    • Lean Manufacturingunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Requirementsunmatched
    • Medical Equipmentunmatched
    • On Site Supportunmatched
    • Operational Strategyunmatched
    • Oracleunmatched
    • Order Picking/Packingunmatched
    • Organizational Skillsunmatched
    • Physical Demandsunmatched
    • Product Lifecycle Managementunmatched
    • Product Supportunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Record Keepingunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Safety Complianceunmatched
    • Safety Processunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched
    • Technical Writingunmatched
    • Testingunmatched

    Description

    Essential Duties and Responsibilities
    The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
    Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
    Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements. Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
    Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
    Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
    Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
    Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
    Collaborate with Engineering to provide feedback on documentation improvements and process changes.
    Support Incoming, product returns and calibration teams as needed as needed.
    Perform other duties as assigned by leadership to meet organizational and operational needs.
    Excellence through Integrity, Compliance, Safety and Environment
    Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
    Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
    Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
    Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
    Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
    Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
    Participate in regular training and complete all training on time.
    Qualifications
    Education
    High school degree and/or an equivalent technical school education preferred.
    Experience
    Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.
    Experience with Oracle, and Agile preferred.
    Skills
    Strong attention to detail and accuracy in reviewing documentation and inspection processes.
    Ability to work independently with minimal supervision and make informed decisions.
    Excellent interpersonal and communication skills for effective collaboration across teams.
    Thorough understanding and application of Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
    Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry.
    Ability to interpret engineering drawings, specifications, and technical documentation.
    Proficient in using quality tools, metrics, and software systems, including Oracle and Agile (preferred).
    Organizational skills to maintain accurate records, logs, and reports.
    Commitment to continuous improvement and fostering a culture of operational excellence..
    Physical Demands
    The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
    Sit; use hands or fingers, to handle or feel objects, tools, or controls.
    Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
    Lifting/pushing/pulling and carrying products weighing up to 45 pounds
    Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
    Potential Exposure to hazardous chemicals or other materials.
    Safety Shoes compliant with site specific policies/procedures must be worn in designated areas
    Potential Exposure to blood.
    Exposure to biological specimens (biohazards).
    Other (please specify): Hepatitis B vaccination required.
    Exposure to biological specimens (biohazards).
    Other (please specify): Example: Hepatitis B vaccination required.
    N/A to all boxes above not checked
    ----------------------------------------
    Please rank your preferred top 3 skill sets: (For Example: tools, previous experience, technologies):
    1: Knowledge of Quality Documents and processes
    2: Attention to detail
    3: Reliablity

    Must have skills: Knowledge of Quality Documents and processes
    Teachable skills: Computer
    Optional skills:

    How quickly are you looking to interview/hire? As soon as possible

    Any possibility of extension or eventual conversion? Extension is possible and eventual conversion I would not know until later this year

    Is this a 100% onsite role?: Yes
    Can this position work hybrid? (please provide arrangement if so): No
    Can this position be fully remote?: No

    Desired years of experience: 3
    How many years of experience would you consider overqualified?: 20
    How many years of experience would you consider underqualified?: 1

    Any other critical details to note for our suppliers? (Team size, team dynamic, applicable job titles that would apply if not already listed, opportunity sell points, etc.): None

    Do you have any planned PTO in the near future?: Not at the moment

    Numbers & Facts

    LocationMarlborough, MA (
    Remote
    )

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