Quality Engineer III

4 weeks ago

Trenton, United States Integer Holdings Corporation Full time

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Essential duties and responsibilities

  • Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
  • Leads and implements various product and process improvement methodologies.
  • Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Leads in the completion and maintenance of risk analysis.
  • Leads generation and completion of protocols and reports for test method validations.
  • Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
  • Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
  • Effectively communicate and interact with customers.
  • Leads and manages complaint investigations.
  • Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Assist with product transfers.
  • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
  • Provides support to other quality engineers.
  • Performs other functions as required.
  • Environmental working conditions
  • Normal office environment

Qualifications

Typically, Bachelor's degree in engineering, equivalent degree or extensive work experience Five to seven years' experience in medical device or other regulated manufacturing Must be familiar with and understand recognized regulations and standards such as (where applicable)

  • 21 CFR Part 820 (FDA QSR, cGMP)
  • EU - Medical Device Directive (MDD) 93/42/EEC
  • ISO 9001 Quality Management Systems
  • ISO 13485 - (EN) ISO 13485 Medical Devices - Quality Management Systems
  • ISO 14971 Risk Management

Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerancing and mechanical drawings and associated software packages. Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills. Ability to interface with customers, problem solve and drive solutions to meet customer requirements. Strong communicator with internal and external customers in all areas of the business: written and verbal (one-on-one and group). Rational thinker: good business judgment and ethics. Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change. Self-motivated with a sense of urgency and accountability. Energetic and hardworking. High level of intellectual curiosity combined with strong problem solving and analytical skills. Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions. Proficient in Microsoft Office and Minitab

U.S. Applicants: EOE/AA Disability/Veteran

  • Quality Engineer

    4 weeks ago

    Trenton, United States LHH Full time

    RESPONSIBILITIES : Participate in daily cross functional interaction and teamwork with Engineering, Operations, Suppliers and Customers Monitor quality control systems to ensure effectiveness and efficiency Collect and analyze production data to evaluate product quality and stop production if serious product defects are present Drive root cause analysis and...

  • Quality Engineer

    3 weeks ago

    Trenton, United States ALLTECH CONSULTING SVC INC Full time

    Responsibilities: * Provide high-level test effort estimate * Create detailed and well-structured test plans and test cases * Set up a test harness to test functionality * Automation feasibility study, development & maintenance of API, functional, integration and load/performance scripts across platforms * Build, deploy application & conduct manual and...

  • Quality Engineer

    2 weeks ago

    Trenton, United States Analog Group Inc Full time

    The Quality Engineer will be responsible that the product quality, product durability and product reliability are assured, and that Corporate Quality and Environment systems are established, implemented and maintained. The position is located in NJ. Candidate should have product experience in quality, quality systems, VCSEL, or laser or GaAs. Acting as a...

  • Quality Engineer 2

    3 weeks ago

    Trenton, United States Pacer Staffing Full time

    Title: Quality Engineer 2 Location: Flanders NJ USA 07836 Duration: 10+ Months (Possible Extension) Shift Hours: Mon – Fri (8am to 5pm) Job Description This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional...

  • Supplier Quality Engineer

    2 weeks ago

    Trenton, United States Staffing the Universe Full time

    Title- Supplier Quality Engineer Job location-Flanders, NJ-07836 Pay Rate- $50/hour on W2 Duration- 12 Months Description Responsibilities Lead initiatives to improve quality received from assigned suppliers Support the qualification of parts and/or introduction of new suppliers Manage supplier’s corrective action implementation through the Supplier...

  • Senior Quality Engineer

    4 days ago

    Trenton, United States Catalyst Life Sciences Full time

    Opportunity to join a global medical device company currently going through a transition and investing heavily into the Quality team. Responsibilities Develop and improve inspection methods to analyze product quality Improve product quality by making recommendations for change Work together with relevant teams and departments to improve products Ensure...

  • Resident Engineer/Senior Inspector

    3 weeks ago

    Trenton, United States Hirebridge Full time

    Ranked the overall #4 Best Civil Engineering Firm to Work for in the Nation (#1 in our size category), and residing on the list of the Engineering News Record (ENR)’s Top 500 Design Firms in the nation, TPD (Traffic Planning and Design, Inc.) is currently hiringexpert Resident Engineers. Our ideal candidate has experience on highway and bridge projects...

  • Sr Quality Compliance Engineer

    4 weeks ago

    Trenton, United States Terumo Medical Corporation Full time

    Job Summary The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutical, and software products through collaborative partnerships and out-reach with...

  • Quality Engineer-Medical Device Software

    2 days ago

    Trenton, United States Scientific Search Full time

    Quality Engineer Medical Device Software Location: Warren, NJ Hyrbid Summary: Step into the role of Quality Engineer at a global leader in specialized diagnostics and medical devices. This pivotal position focuses on Software as a Medical Device (SAMD), ensuring all software complies with critical regulations. If you have expertise in quality assurance...

  • Quality Auditor

    2 weeks ago

    Trenton, United States H & H Inc Full time

    We are offering an exciting opportunity for a Quality Auditor in our Hamilton, NJ office. The Quality Auditor will carry out internal H&H project audits for ongoing design and construction projects. The audits focus on the inspection of the project's quality control documents and system. The Quality Auditor will prepare audit reports and assessments and...

  • Mechanical Engineer

    3 weeks ago

    Trenton, United States Parette Somjen Architects Full time

    Mechanical Engineer (MEP Design - Quality Control) About us: Parette Somjen Architects (PSA) is a full-service architectural design firm in Morris County, New Jersey. We are a fun and fearless organization with a passion for our work. We provide architectural and design services for commercial, public, and private sector clients across NJ and the tri-state...

  • Quality Control Manager:

    3 days ago

    Trenton, United States Synerfac Full time

    Details: Work directly for a Somerset County New Jersey area company of industrial interconnect products. Quality Control Manager: Summary: As a Quality Control Manager, you will play a pivotal role in ensuring the highest standards of quality throughout our assembly processes. You will be responsible for developing and implementing quality control...

  • Quality Control Manager:

    2 days ago

    Trenton, United States Synerfac Full time

    Work directly for a Somerset County New Jersey area company of industrial interconnect products. Quality Control Manager: Summary: As a Quality Control Manager, you will play a pivotal role in ensuring the highest standards of quality throughout our assembly processes. You will be responsible for developing and implementing quality control procedures,...

  • Engineer

    3 weeks ago

    Trenton, United States Automann USA, Inc. Full time

    Education: Sr. Mechanical Engineer, Master’s degree in Mechanical Engineering with 2 years of experience Deadline: 2024 years ago Sr. Mechanical Engineer, Master’s degree in Mechanical Engineering with 2 years of experience Implement PPAP (Product Part Approval Process) and produce first article inspection reports to record the design, development, and...

  • Network Engineer III

    4 weeks ago

    Trenton, United States Crossfire Consulting Full time

    Network Engineer - Fully remote W2 only - No C2C Key responsibilities for Network Engineer: Advanced configuration and OS upgrades of carrier-class Cisco, Juniper, Nokia equipment for complex, nationwide data network Work on virtualization technologies in Pacific and North Central markets Assist with COIN implementation and work with...

  • Manager, Quality Management Systems

    19 hours ago

    Trenton, United States Tris Pharma Full time

    Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have...

  • Senior Director

    4 weeks ago

    Trenton, United States Enzene Biosciences Full time

    We are looking for a Senior Director, Quality Assurance to lead our US Quality operations and ensure compliance with global regulatory standards and customer expectations. You will be responsible for overseeing the quality systems, processes, and personnel at our state-of-the-art biopharmaceutical manufacturing facility in the US. You will also be a key...

  • Quality and Continuous Improvement Manager

    3 weeks ago

    Trenton, United States Plastipak Holdings Full time

    Quality and Continuous Improvement Manager page is loaded Quality and Continuous Improvement Manager Apply locations Plastipak - Keasbey, NJ time type Full time posted on Posted 2 Days Ago job requisition id REQ17061 As a key member of the Site Leadership Team, you manage Quality Assurance and related Continuous Improvement initiatives within the...

  • Electrical Engineer

    3 weeks ago

    Trenton, United States Parette Somjen Architects Full time

    Electrical Engineer (MEP Design - Quality Control) About us: Parette Somjen Architects (PSA) is a full-service architectural design firm in Morris County, New Jersey. We are a fun and fearless organization with a passion for our work. We provide architectural and design services for commercial, public, and private sector clients across NJ and the tri-state...

  • Design Engineer

    2 days ago

    Trenton, United States Vaco Full time

    Design Engineer Contract Onsite: near Jersey City, NJ Responsibilities:Utilize CAD software for design modeling and optimization.Collaborate with Product Development Engineers and surgeons to define design inputs.Assist in prototype manufacture and testing.Support quality, regulatory, and marketing projects.Requirements:Bachelor's degree in engineering or...