4 Manufacturing jobs in Harrisonburg

Overview
M.C. Dean is _Building Intelligence®_ . With more than 5,800 professionals worldwide, we design, build, operate, and maintain cyber-physical solutions for mission-critical facilities, secure environments, complex infrastructure, and global enterprises. We pursue innovative and challenging work that has a meaningful impact by powering, automating, integrating, and securing the world's most critical infrastructure and facilities. This translates into fulfilling opportunities for employees driven to excel in a meaningful career.
We're seeking people driven to excellence and inspired to have a?meaningful impact powering, automating, integrating, and securing the world's most critical infrastructure and facilities. This translates into fulfilling opportunities for employees driven to excel in a meaningful career. As an employee at M.C. Dean, you will join forces with more than 5,800 professionals who engineer and deploy automated, secure and resilient power and technology systems; and deliver the management platforms essential for long-term system sustainability. Together, we transform the way complex, large-scale systems are designed, delivered, and sustained-enhancing client outcomes, improving lives, and changing the world for the better.
The Quality Control Inspector is responsible for following the M.C. Dean Quality Control (QC) Program to achieve and verify quality expectations for a durable and reliable installation. The Quality Control Inspector is responsible for performing field inspections to ensure work is in compliance with all safety policies and procedures.
Responsibilities
+ Conduct inspections to ensure compliance and conformance with project or contract specifications
+ Conduct inspections in accordance with Quality Control Plan Conduct inspections to ensure adherence to applicable legal requirements
+ Confer with Quality Assurance, Manager as appropriate
+ Read blueprints and specifications
+ Monitor operations to ensure that they meet specifications
+ Recommend adjustments to the assembly or installation process
+ Inspect, identify, and submitmaterial, components, or products for testing and measurement
+ Operate electronic inspection equipment and software
+ Document approval or rejection of inspected material, components, or products
+ Identify for removal all components, products and materials that fail to meet specifications
+ Report inspection and test data and quantities inspected
+ Participate in the Preparatory Meeting for each definable feature of work to review pertinent sections of the plans and specs requirements with the foreman supervising the work.
+ Participate in Initial Inspection to assure all required/approved materials, personnel and equipment are available, verify the site conditions, inspect the initial installation of the work and identify the required level of workmanship, quality, and safety measures
+ Participate in Follow-up Inspections continuously to insure professional workmanship, quality and safety in accordance with contract documents.
+ Perform inspections on all work performed in detail, efficiently, and in conjunction with Owner/QC.
+ Collect data, analyze for continuous improvement, and share with project team weekly.
+ Participate in the daily Operational Risk Management (ORM) meetings ensuring
+ Quality items/issues for the scope of the work are discussed and present at least 2-3 quality tips of the day relevant to the scope of work.
+ Document daily QC reports Understandi and follow all applicable quality system procedures, performing all assigned responsibilities outlined in the QMS.
+ Perform Receiving (REC), First Article (FAI), In-Process (IP) and Final Inspections (FI) on electrical and mechanical assemblies visually and/or with inspection equipment.
+ Immediately notify operators, or supervision of any non-conformances in products
+ Perform all quality reporting requirements outlined in the MCD Quality Management System (including the inspection checklists, Data Collection Reports (PDCR), hold logs, discrepancy notices, waiver logs etc.)
+ Identify for segregation nonconforming units following the MCD Nonconformance procedure for prefabricated and purchased products.
+ Assist in the training of operators and provide guidance.
+ Assist in the problem-solving process.
+ Participate in the Daily ORM work briefings to represent the Quality Portion.
+ Assist in root cause, corrective and preventive action development for systemic issues.
+ Advise appropriate party of any corrective action to be taken.
+ Coordinate with supervisor to ensure all shifts are covered appropriately in case of absence of an inspector.
Qualifications
+ Associates Degree in Technical Discipline (may be substituted for quality related experience)
+ At least 4 years hands-on experience in construction, estimation, and/or quality control activities.
+ Experience with reading and interpreting contractual requirements, drawings, BIM models, specifications, current NEC codes, NETA and other applicable standards
+ Experience with receiving, production, shipping and quality processes.
+ Excellent communication skills (written, and verbal)
+ Strong attention to details, highly organized and computer literate.
+ Ability to work well in a fast-paced manufacturing environment
Abilities:
+ Exposure to computer screens for an extended period of time.
+ Sitting for extended periods of time.
+ Reach by extending hands or arms in any direction.
+ Have finger dexterity in order to manipulate objects with fingers rather than whole hands or arms, for example, using a keyboard.
+ Listen to and understand information and ideas presented through spoken words and sentences.
+ Communicate information and ideas in speaking so others will understand.
+ Read and understand information and ideas presented in writing.
+ Apply general rules to specific problems to produce answers that make sense.
+ Identify and understand the speech of another person.

**Job Requirements**
This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.
Position Overview:
Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director). This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products.
Our team works with a "Safety First, Quality Always" mindset. As the primary point of contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business partnership and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management.
The Associate Director, External Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies. This role will help build and maintain strong collaboration with a wide range of professional disciplines in Research, Manufacturing, and Commercial Operations - as we continue to drive growth in this area of our business.
Primary Responsibilities and Activities include but are not limited to:
· **Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:**
- Build a strong interdependent relationship with External Partner Site and Plant Leadership Team.
- Create and maintain an inclusive culture and high-performing team (coaching team members as required).
- Ensure "Right First Time" mindset. Consistently deliver On-Time and In-Full - with First Pass Quality.
- Oversight and presence on the production floor at External Partner site(s).
- Maintain adherence to terms in the Supply Agreement and Quality Agreement - ensuring alignment with the Master Supply Agreement (MSA).
- Dispute and Issue Resolution (with appropriate escalation as required).
- Resolve Technical Issues (Investigations, CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management).
- Lead Periodic Business and Operations Review Meetings (with External Partner).
· **Compliance:** Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).
· **Supply Chain Management:** Manage coordination with End-to-End Product Supply Chain nodes (upstream and downstream) to ensure timely and optimized flow of materials. Demand Management, E2E Production Planning, Materials Management, Logistics, and SAP Entries as needed.
· **Continuous Improvement:** Assess current condition and risks at External Partner site (using appropriate tools and resources). Establish baseline KPI and trends as leading indicators of supplier performance at launch and throughout product lifecycle. Formulate actionable and time bound improvement plans.
· **Financial Stewardship** : Manage Budget, Estimated Actuals, and Accruals for projected spend (Expense, Capital/Prepaid, and Product Cost as required). Provide input into annual ExM Operations Profit Planning process.
· **Commercialization of New Products:** Support of sourcing and siting activities, evaluation of supplier capabilities, participation in on-site due diligence visits, help determine equipment/facility investment requirements, and provide Operations input into Supply and Quality Agreements.
· **Launch Supply Risk Mitigation:** Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production Oversight.
Minimum Education Requirement:
· Bachelor's Degree required. Degree in Engineering or Science strongly preferred.
REQUIRED Experience and Skills:
· **No less than eight (8) years of experience in Biopharmaceutical industry across multiple manufacturing disciplines** (Operations, Quality, Technology, Engineering, Supply Chain, etc.). At least five (5) years leading teams and/or projects. At least three (3) years in direct management of shop floor production activities.
· **Project Management** - Proficient with Project Management and Virtual Collaboration Tools (Microsoft Project, OneNote, Teams, SharePoint, Action Trackers, Risk Trackers, Decision Logs, etc.).
· **Communication** - Excellent communication and presentation skills (written and verbal). Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).
· **Integrity** - Stewardship of Company Intellectual Property. Ability to assess appropriate level of information disclosure and maintain confidentiality when dealing with multiple internal and external stakeholders.
· **Supplier Relationship Management** - Ability to manage supplier relationships across a spectrum of strategic priorities and influence.
· **Business & Financial Acumen** - Ability to forecast and manage operating budgets (Expense, Capital/Prepaid, and Product Cost). Understanding of industry and economic data to make business decisions that drive value for our Company and our customers.
· **Compliance** - Deep understanding of Good Manufacturing Practices (GMP) and Environment & Safety Regulations.
· **Deep Manufacturing Knowledge** - Proven expertise in various manufacturing processes, equipment, labor relations, and production best practices.
· **World Class Supplier Mindset** - Demonstrated ability to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time.
· **Strategic Thinking** - Ability to identify opportunities that add value to the work - proactively mitigating risk across the value chain.
· **Working Across Boundaries** - Excellent interpersonal and networking skills. Demonstrated ability to build relationships and collaborate with internal and external partners as the normal way of working.
· **Drive Results and Business Outcomes** - Ability to use deep knowledge and expertise in Manufacturing, Technical, and Quality Operations to drive results and business outcomes.
· **End-to-End Mindset** - Ability to apply understanding of end-to-end supply chain (within external and internal network) to achieve results and optimize supply chain.
· **International Experience** - Ability to effectively engage and collaborate with diverse cultures across the globe.
PREFERRED Experience and Skills:
· **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. Experience with OEB 4 / OEB 5 compounds is a plus.
· **New Product Introductions** - Knowledge of Pharmaceutical product development and commercialization. Awareness of MDCP development and commercialization is a plus.
· **Process Improvement** - Knowledge of lean principles, equipment design, and preventative maintenance.
· **Regulatory** - Global regulations and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device Regulation, etc.).
· **Strategic Sourcing and Contract Negotiation**
**Requisition ID:** P-100912