ASQ NJIT Student Chapter Presentations on November 10th, 2014

Join the ASQ NJIT Student Chapter for two presentations at NJIT!

  1. Visual Factory Management Based on IIoT (The Industrial Internet of Things) Methods and Technologies (by Paul G Ranky, PhD, NJIT)
  2. Visual Programming of Universal Robots (by Jake Huckaby, PhD, Universal Robots, New York)

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ASQ NJIT Student Chapter Presentations on October 28th, 2014

Join the ASQ NJIT Student Chapter for two presentations at NJIT!

  1. Visual Factory Management Based on IIoT (The Industrial Internet of Things) Methods and Technologies (by Paul G Ranky, PhD, NJIT)
  2. Visual Programming of Universal Robots (by Jake Huckaby, PhD, Universal Robots, New York)

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Quality Engineering Manager (Billerica, MA)

As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

Bruker Daltonics as an immediate need for a Quality Engineering Manager in our Billerica, MA headquarters. The Quality Engineering Manager is a hands-on functional leader who collaborates with engineering, marketing, sales, operations, and other functional groups to design, develop, implement, and manage the full battery of quality management systems, processes and procedures to ensure compliance to requisite regulatory requirements and to drive lean, effective quality management systems through the entire product life cycle. The ideal candidate is a self-motivated individual who thrives on a dynamic, fast-paced environment and being part of a highly-skilled technical team.

Responsibilities:

• Mentor, develop, and manage assigned direct reports
• Complete & deliver annual performance reviews
• Develop, implement, and manage Quality Management Systems processes and procedures which are compliant with the FDA QSR (21 CFR 820), ISO 13485, and ISO 9001
• Drive effective QMS processes from a Quality Engineering perspective with specific focus on Design Controls (21 CFR 820.30)
• Lead effective CAPA initiatives from concept through effectiveness verification
• Prepare technical test protocols and reports (e.g. Design Verification / Validation) which comply with 21 CFR 820.30
• Collaborate with engineering to qualify suppliers, components, etc.
• Lead QMS process improvement efforts and QMS lean initiatives

Qualifications:
• 10 years minimum experience in quality engineering discipline focusing on design controls; risk management; complaint handling; MDR reporting; CAPA; supplier quality management; and other industry-standard quality engineering functions.
• Bachelor’s degree in physics or engineering (electrical, mechanical, chemical, or biomedical; other technical disciplines may be considered)
• Extensive hands-on experience applying the FDA QSR (21 CFR 820) is mandatory.
• Extensive working experience at an OEM medical device manufacturing company is mandatory.

Please apply at http://www.bruker.com/about-us/career.html.

Bruker Corporation offers a comprehensive and competitive benefits package including medical, dental, 401(k), paid vacation, holidays, and tuition assistance (as applicable). Bruker is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Senior Quality Engineer – Product Complaints (Billerica, MA)

As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

New opportunity in the Bruker Daltonics business unit based in Billerica, MA, which manufactures FDA-cleared In Vitro Diagnostic (IVD) devices, for a Senior Quality Engineer – Product Complaints. This position involves tasks and activities pertaining to complaints and related quality system activities to ensure compliance with FDA 21 CFR 820 requirements. The ideal candidate is a self-motivated individual who thrives as part of a highly skilled technical team within a dynamic and fast-paced work environment.

Responsibilities:
•Facilitate and Manage product complaint reports from initiation through closure.
•Investigate and process customer complaints to facilitate closure in a timely manner; File MDR reports as applicable.
•Collaborate with Engineering, Production and other functions to assure timely completion of corrective and preventive actions (i.e. revisions/changes to quality specifications, test methodologies, design specifications, risk management documents, and sampling plans).
•Analyze service reports for potential complaints and MDR reporting; file MDR reports in a timely manner.
•Support product / process improvement efforts utilizing methodical problem-solving approaches for corrective actions from complaints.
•Implements methods to capture the appropriate metric data; and applying the appropriate statistical analysis method(s) for reporting complaint metrics to management.
•Reports to Quality Engineering with accountability for implementing and maintaining robust Complaints and MDR processes; driving resolution of quality issues by monitoring quality metrics, recruiting key team members for timely closure, and ensuring effective corrective and/ or preventive actions from complaints.
•Perform other duties as required.

Qualifications:
•Bachelors of Science Degree in a technical discipline.
•Minimum 10 years of Quality Engineering experience with emphasis on complaints, MDRs and technical problem solving within an FDA-regulated medical device manufacturing environment.
•Demonstrated hands-on medical device experience under US 21 CFR 820 requirements; working knowledge of 21 CFR 803 and 809 a plus.
•Understanding of documentation management and records, change control/ECOs and other QSR elements.
•Strong technical presentation skills, including advanced MS Office proficiency. Proven familiarity of Minitab and SAP would be a plus
•Recent hands-on experience applying methodical problem-solving techniques and fundamental statistical data analysis methods is desirable.
•Experience interacting directly with external customers, desirable.
•Excellent verbal, written, telephone, and interpersonal communication, presentation, and organizational skills, including ability to interface with multiple levels and affiliates.

Please apply at http://www.bruker.com/about-us/career.html.

Bruker Corporation offers a comprehensive and competitive benefits package including medical, dental, 401(k), paid vacation, holidays, and tuition assistance (as applicable).
Bruker is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics

Supplier Quality Engineer position available (Bloomfield, CT)

The Supplier Quality Engineer plans and directs activities concerned with development, application and maintenance of quality standards for industrial processes, materials, and products with the Jacobs Vehicle Systems supply base. This position is an excellent developmental position for candidates aspiring to transition into a role of greater responsibility within Jacobs Vehicle Systems or Danaher. Continue reading

ISO 9001: 2015 – What to expect and how to survive the new revision

The November 2014 section meeting will focus on the changes in the upcoming ISO 9001:2015 edition of the international quality management standard, exploring some of the new requirements, and the new challenges that will be faced by users, along with “survival strategies” for navigating the future.
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