Senior Supplier Quality Engineer

Merck Group • $104K — $188K *
Burlington, MA 01803In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical or Biomedical Engineering, or related field.
  • 3+ years in quality assurance or engineering role within supplier management in biotechnology.
  • 1+ years of Supplier Quality Management experience.
  • Strong oral and written communication skills.
  • Practical knowledge of stainless steel machining, Nickel Plating, filtration technologies, and relevant mechanical components is an advantage.

Responsibilities

  • Lead supplier problem-solving activities using CAPA methodologies like 8D and 5Why.
  • Manage supplier yield reporting and drive continuous quality improvements.
  • Conduct supplier quality review meetings to follow-up on issues and corrective actions.
  • Perform supplier audits for ISO standards and create audit reports.
  • Support key metrics achievement regarding customer complaints by leading engineering change requests.
  • Develop documentation for product/process changes as part of qualification and validation.

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Potential sales or performance-based bonuses
  • Perquisites including additional perks
Full Job Description
Your Role:

As a Supplier Quality Engineer, you will independently manage and collaborate with suppliers, to ensure on-time delivery, resolve quality and production issues, drive continuous improvement, and act as the primary liaison between suppliers and internal cross-functional teams, conducting audits, monitoring performance, and fostering strong, trust-based partnerships to ensure compliance with quality, customer, and regulatory standards.

Key Responsibilities:
  • Lead and facilitate problem-solving activities with suppliers using methodologies like 8D, 5Why, and Ishikawa diagrams to implement effective corrective and preventive actions (CAPA).
  • Lead supplier quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement of quality and efficiency of external manufacturing operations.
  • Lead supplier quality review meetings to ensure follow-up of issues and implementation of Corrective and Preventative actions.
  • Perform supplier and internal audits for ISO 13485 and ISO 9001 and develop corresponding audit reports.
  • Support the achievement of key site metrics, such as complaint reduction, by leading Engineering Change Requests related to manufacturing specifications, drawings, and procedures, and by providing technical assistance to resolve customer complaints and chronic supplier issues.
  • Develop qualification and validation documentation to support changes to existing products and/or processes.
  • Collaboration and development of Incoming Quality requirements and Statistical analysis of incoming and Supplier process data.
  • Drive continuous improvement initiatives to enhance performance, quality and efficiency of external suppliers.
  • Support of the new product introduction process
  • Managing change control and replacement due to obsolescence of components


Who You Are

Minimum Qualifications:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or other Engineering discipline.
  • 3+ years of work experience in quality assurance or quality engineering role within supplier management in the biotechnology industry.
  • 1+ years of work experience in Supplier Quality Management.
  • Excellent oral and written communication skills
  • Practical knowledge of stainless steel machining, Nickle Plating passivation, media/filters, chemicals, O-rings/gaskets, and Mixer motors and control boxes, Plastic welding gained through 3+ years of work experience is a plus.
  • Must have demonstrated ability to perform failure analysis of customer complaints gained through 1+ years of work experience.
  • Excellent analytical, problem-solving and decision-making skills; self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks with varying requirements and deadlines.
  • Create, review, and approve Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Master Validation Plans (MVP), and Product Validations (PV) gained through at least 1+ years of work experience.


Preferred Qualifications:
  • Master's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or other Engineering discipline and 1+ years of experience in process/quality engineering and supplier management in biotechnology industry.
  • TrackWise, SAP, Oracle, ManGo, Veeva experience is a plus
  • Knowledge of current ISO and cGMP standards and lead audit experience for supplier and internal audit gained through 1+ years of work experience is a plus.
  • Experience with new product introduction and buy/resell processes is a plus.
  • Experience managing Mechanical suppliers is a plus.


Pay Range for this position: $104,300 - $188,000

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.

Direct link to benefits site if the hyperlink no longer works: https://careers.emdgroup.com/us/en/benefits].

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

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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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