Manager, Quality Engineering
Company: Disability Solutions
Location: Woburn
Posted on: May 2, 2024
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Job Description:
Abiomed, a part of Johnson& Johnson MedTech, is currently
recruiting for a Manager, Quality Engineering. This position is
based in Woburn, MA At Johnson & Johnson, we believe health is
everything. Our strength in healthcare innovation empowers us to
build a world where complex diseases are prevented, treated, and
cured, where treatments are smarter and less invasive, and
solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at https://www.jnj.com/. Abiomed, part of
Johnson & Johnson MedTech, is a leading provider of medical devices
that provide circulatory and respiratory support, with a mission of
recovering hearts & saving lives. Abiomed's "Patients First!"
culture drives our skilled workforce and strong relationships with
clinicians. Our innovative product portfolio and robust pipeline
provide us the incredible opportunity to bring lifesaving
technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth,
integrity and innovation. Summary Manages the day-to-day operations
of the Quality Engineering staff at the Woburn facility of Abiomed
(a Johnson & Johnson company). Oversees the development and
implementation of processes, procedures, audits and corrective
actions for the manufacture of medical device components. Ensures
effective communication and training are deployed throughout the
business. Job Description Maintains quality records on product
testing, nonconformance, project outcomes, and stakeholder input
filed in an accurate and timely manner. Coordinates change control
documentation and approval process. Makes proposals and in the
development of corrective action plans and monitors implementation.
Follows up on closure of corrective and preventive actions.
Provides quality support for technology transfer and improvement of
existing manufacturing processes. Conducts investigations, collects
data, analyzes trends and prepares reports for assigned quality
processes. Assesses current quality systems and recommends
improvements in order to enhance quality and reduce cycle time.
Prepares for and facilitates audits and inspections. Monitors
trends, identifies issues, recommends and implements appropriate
actions. Assists in the development, implementation and review of
standard operating procedures. Leadership and Team Management: ---
Provide leadership and direction to the quality engineering team.
Coach and mentor team members, lead professional development
discussions, drive employee engagement. --- Advise multi-functional
managers on high-level initiatives for Quality Engineering,
employing industry best practices to ensure optimal results. ---
Integrates Johnson & Johnson's Credo and Leadership Imperatives
into team goals and decision making. --- Responsible for the
operational aspects of their team (e.g., workflow, performance, and
compliance), as well as ensuring achievement of team goals within
established timelines and budgets. Quality Assurance: ---
Collaborate with cross-functional teams to establish and maintain
quality assurance processes throughout the manufacturing lifecycle
(NPI through end of life) --- Own the manufacturing MRB Process
through sustaining and improvement activities. Use data generated
from MRB to drive improvements to the manufacturing and quality
system process. --- Audit technical support activity to production
areas in evaluating process improvement opportunities and
subsequent modifications, to produce timely and effective Quality
Engineering solutions. --- Examine results from management reviews,
third party inspections and internal audits and approves proposed
corrective actions. --- Evaluating and implementing improved
manufacturing engineering performance management systems and
tracking tools, as well as facilitating resolution of complex
technical, quality and operational problems. --- Ensure adherence
to Good Manufacturing Practices (GMP) and other relevant quality
standards through document reviews, Gemba walks, and influencing
other functions to embrace a quality culture and mindset. --- Lead
process validation efforts, ensuring that manufacturing processes
are validated according to Abiomed's SOP's and industry best
practices. --- Implement statistical tools and methodologies for
process optimization and control (IQ, OQ, PQ, PPQ, TMV, Gauge RR,
Cpk, SPC).
Keywords: Disability Solutions, Haverhill , Manager, Quality Engineering, Engineering , Woburn, Massachusetts
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