Quality Engineer

Merck Group • $67K — $101K *
Jaffrey, NH 03452In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, or a related technical field.
  • 1+ years of experience in Quality Engineering or a related technical role in a regulated environment.
  • Master's degree in Engineering or a related technical discipline is preferred.
  • 2+ years of experience in Quality Engineering within a regulated manufacturing setting is a plus.
  • Familiarity with ISO & FDA regulations pertinent to quality management is necessary.
  • Experience with leading investigations and defining corrective actions is beneficial.
  • Proficiency in data analysis tools, particularly Minitab, and knowledge of Electronic Quality Systems.

Responsibilities

  • Provide quality engineering guidance for handling non-conforming products and materials.
  • Lead investigations for internal failures and customer complaints using structured methodologies.
  • Conduct product/process risk assessments and collaborate with cross-functional teams to solve quality issues.
  • Guide product and process changes, ensuring compliance and proper documentation.
  • Establish acceptance criteria for validation and equipment qualifications through statistical methods.
  • Create, revise, and implement Standard Operating Procedures and Test Methods.
  • Perform statistical analysis to monitor product or process performance.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Potential sales or performance-based bonuses.
Full Job Description
Your Role

We are seeking a motivated Quality Engineer to join our team supporting device manufacturing at the Jaffrey site. This role provides support in ensuring product quality, compliance with cGMP, ISO, and internal Quality Management System (QMS) requirements, and managing investigations within a fast-paced, regulated manufacturing environment. Duties include:
  • Provide quality engineering guidance for the disposition of non-conforming products and raw materials using risk based and GMP compliant approaches.
  • Lead investigations related to internal failures, customer complaints, and process excursions using structured methodologies (e.g., Fishbone, 5 Why); ensure investigations are thorough, timely and drive robust CAPAs.
  • Lead and/or participate in product/process risk assessments (e.g., FMEA) and partner with cross-functional teams to resolve quality issues impacting filter production yield, and customer delivery.
  • Provide guidance and support for product and process changes by collaborating with the cross-functional team ensuring changes are risk based, documented, and implemented in compliance with internal procedures and applicable industry standards and regulations.
  • Provide guidance for product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, performing data analysis, and reviewing validation protocols and reports
  • Create or revise Standard Operating Procedures, Test Methods and other documents.
  • Perform statistical analysis and trending to assess and monitor product or process performance.
  • Provide guidance and support for shelf-life studies both accelerated and real-time aging, including protocol creation, data analysis, out of specification investigation, and report creation.

Who You Are

Minimum Qualifications
  • Bachelor's degree in Engineering, Science, or other technical discipline (e.g., Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biology, Chemistry, or a similar field).
  • 1+ years of experience in Quality Engineering or other technical role in a regulated manufacturing environment.

Preferred Qualifications
  • Master's degree in Engineering, Science, or other technical discipline (e.g., Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biology, Chemistry, or a similar field).
  • 2+ years of experience in Quality Engineering or other technical role in a regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
  • Working Knowledge of ISO & FDA regulations (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211).
  • Demonstrated experience leading quality investigations including root cause analysis and defining corrective/preventative actions.
  • Strong communication skills with the ability to collaborate with Customers and across all organizational levels
  • Pragmatic, risk-based decision-maker with strong problem-solving skills.
  • Collaborative and motivated team player with experience using data analysis tools such as Minitab and working knowledge of Electronic Quality Systems including CAPA, Change Control, and documentation management processes.
  • Lean/Six Sigma Green or Black Belt certification and ASQ Certified Quality Engineer (CQE) credentials.


Pay Range for this position: $67,700.00 -$101,600.00 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.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

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READ CAREERS BLOG

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.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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