Quality Engineer II at DivIHN Integration Inc

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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Abdul |

Title: Quality Engineer II

Location: Tewksbury, MA

Duration: 10 Months

Description:

• Support the standardization of quality engineering systems, architecture, and specifications across Division manufacturing facilities
• Support actions for streamlined validation processes to ensure conforming, compliant product is made available to customers in a timely manner
• Participate in problem solving and root cause analysis activities (e.g. CAPAs, SCARs) internally and with suppliers and customers to eliminate recurrence of nonconformances and ensure continuity of supply
• Conduct supplier audits as needed to meet requirements
• Support actions to drive process standardization, waste elimination, and continuous improvement with suppliers
• Conduct division/customer/3rd party audits of internal sites as required
• Actively support new product launches for products manufactured by Client or 3rd party manufactured product for Client which would include Supplier Selection and Qualification and Product Validation.
• Leveraging quality engineering best practices, champion and use standard product life cycle management systems, tools, and outputs:
• Design and Development Controls
• Product Verification and Validation
• Process and Equipment Validation (e.g. IQ/OQ/PQ)
• Product Quality Architecture (PQA)
• Innovation
• Manufacturing Innovation Excellence (MIE)
• Manufacturing Scalability Playbook (MSP)
• Other Performance Excellence (PEx) tools as appropriate (e.g. Six Sigma tools, FMEA, DoE, Measurement System Analyses, Gauge Repeatability and Reproducibility (RandR), DMAIC, Manufacturing Engineering Excellence (MEE), Lean, etc.)
• Supplier Performance and Quality Management
• Lead Quality projects of small scale and complexity
• Participate in and sometimes lead Quality lead on projects of moderate scale and complexity
• Supporting Quality lead on projects of sizable scale and complexity
• Proficient on industry-relevant customer expectations (e.g. sterility, leachables/extractables, in vitro and in vivo toxicity, biological and chemical contamination sources and mitigation, etc.)
• Support in the creation of technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.)
• Author Design History Files, customer-facing validation guides, change notifications/validation summaries, product certifications, and instructions for use literature
• Some travel is required as part of the job responsibilities.

Experience:

Required:

• BS Degree in an engineering, scientific, or statistical field
• Minimum of 3 years of manufacturing quality or related engineering experience.
• 0-2 years of experience in validation application.
• In depth knowledge of applicable and similar industry requirements (e.g. ISO 9001, ISO 13485, ISO 15378 Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)
• Knowledge of manufacturing processes and relevant statistical methods for quality assurance.

Skills

• Capable of the integration and application of user targeted manufacturing process documentation while meeting business and regulatory requirements.
• Good understanding of Continuous Improvement/PEx Methodologies, including lean, six sigma, statistical applications and validation.
• Working knowledge of relevant software for data collection (e.g. ERP, PI, eQMS), data storage and analysis (e.g. Microsoft Access, Microsoft Excel), project management (e.g. Microsoft Project), statistics (e.g. R, Minitab, JMP), word processing (e.g. Microsoft Word), reporting (e.g. Microsoft Visio, Mindjet MindManager, Microsoft PowerPoint), and communication (e.g. Microsoft Outlook, Microsoft Skype, Microsoft Teams, Microsoft SharePoint, Cisco WebEx).
• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
• Ability to influence individuals without authority and to motivate others within a project team.
• Ability to make data-derived decisions regarding product and process suitability and conformance.
• Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.
• Ability to lead projects and coordinate the efforts of others to complete project goals; must also possess the ability to effectively manage conflict.
• Ability to lead change management and perform other duties as assigned.

Preferred:

• Life Science or Pharmaceutical Packaging product application knowledge and experience.
• Certified Quality Engineer recognition by ASQ.
• Green or Black Belt

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.