NPI Quality Engineer

Merck Group$80K — $138K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant engineering discipline
  • 3+ years of experience in Quality Engineering or similar roles
  • Knowledge of ISO 9001:2015 standards

Responsibilities

  • Collaborate with Product Development and Product Management on new product introductions
  • Provide Quality Engineering guidance between product development and manufacturing
  • Lead creation of risk assessments for products and processes
  • Guide product validations and equipment qualifications
  • Write and approve validation protocols and create/update SOPs
  • Evaluate non-conforming products and lead investigations
  • Support shelf-life studies and data analysis for aging processes

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Sales or performance-based bonuses
  • Other perquisites
Full Job Description
Your Role

We are seeking a NPI Quality Engineer to join our team supporting New Product Introduction in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability.
  • Collaborate with Product Development and Product Management on the introduction of new products and/or line extensions into the Jaffrey facility.
  • Provide Quality Engineering guidance and support for device manufacturing as a liaison between product development and the plant.
  • Lead and participate in the creation of risk assessments (e.g. product and process-FMEA).
  • Provide guidance and support for product validations and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
  • Writes and approves validation protocols and reports, creates and updates SOPs and test methods, and performs data analysis and trending to monitor product quality and process performance.
  • Provide guidance for the disposition of non-conforming product and raw materials. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations (root cause analysis and corrective action plans)
  • Provide guidance and support for shelf-life studies both accelerated and real-time aging including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.


Who You Are

Minimum Qualifications

  • Bachelor of Science degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering or other technical discipline
  • 3+ years of Quality Engineering experience or similar technical role in a regulated manufacturing environment
  • Working Knowledge of ISO 9001:2015 requirements


Preferred Qualifications

  • Master's degree in Mechanical Engineering, Chemical Engineering Industrial Engineering or other Engineering discipline.
  • 5+ years of Quality Engineering experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
  • Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
  • Operate in a complex, matrixed, and fast paced environment and gain consensus with groups
  • Validation experience in a regulated manufacturing industry.
  • Conduct quality investigations including root cause analysis and determining corrective / preventative actions.
  • Pragmatic risk-based decision maker with strong problem-solving ability.
  • Collaborative team player with experience using data analysis tools such as Minitab, electronic quality systems (CAPA, Change Control, and Document Management), and continuous improvement methodologies, including ASQ Certified Quality Engineer (CQE) and Six Sigma Green Belt/Black Belt practices.
  • Demonstrated ability to create and update standard operating procedures ("SOP")


Pay Range for this position: $80,000.00 -$138,100.00 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
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