Senior Engineer, Quality
Company: Rapid Micro Biosystems
Location: Framingham
Posted on: June 16, 2022
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Job Description:
Winning the race to bring new healthcare products safely
to--market--drives Rapid Micro Biosystems (RMB) to combine today's
innovative technologies as never before. Your career at RMB puts
you at the center of diverse global teams that span robotics, AI,
Machine Learning, imaging, microbiology, and more, re-shaping how
urgently needed pharmaceuticals are made, tested, and released for
decades to come. The sky's the limit. Careers at RMB are
fast-moving, with the high growth you'd expect from a world leader
in microbiology automation.--Advancement--at RMB--affords
an--opportunity to achieve--your personal goals and--develop
your--passions, in an inclusive environment where every employee
has the resources and opportunities to hone their skills. You'll do
more, learn more, and--can--make a--profound impact--on our
business. Senior Quality Engineer The Senior Quality Engineer is
responsible for oversight, inspection and testing of product
quality throughout the manufacturing process. --Provide quality
engineering support to manufacturing and suppliers with support
when process changes are required. --The Senior Quality Engineer
shall provide support to developing and implementing systems to
ensure products or services are produced to meet or exceed customer
requirements and expectations. Provide support and oversight to
assigned elements of the companies Quality Management System.
Primary Activities Responsible for performing the in-process and
final inspection/test on products being manufactured to ensure
design and performance requirements are met. Document
nonconformance and deviations as conditions are found and ensure
root cause and corrective actions are defined leading to a final
disposition and closure of the nonconformance. Participate in the
MRB process and the dispositioning of nonconforming product and
components. Provide Quality Engineering expertise to maintain and
improve product quality by investigating customer complaints and
analyzing nonconforming material reports. Prepare the final product
documentation packages and submit for review and approval. Organize
and maintain the archiving of quality records. Support the
continuous improvement of quality processes by revising procedures
and submitting them into the ECO process. Provide support to
Operations, Service and Engineering to drive improvement actions to
meet targeted goals and objectives. Participate in the supplier and
internal audits as assigned and provide support to any resulting
corrective actions to ensure successful closure. Provide input to
and maintain supporting quality metrics (e.g., field,
manufacturing, and inspection) and key process indicators to
identify opportunities for improvement. Skills Skilled in
inspection and testing of complex capital equipment Skilled in
quality system process development, improvement, and auditing
Skilled in failure analysis and root cause determination, CAPA, 8D,
DMAIC, A3, 5-why, fishbone, etc. Good verbal (including
presentation) and written communication skills, especially
technical report writing Ability to effectively lead and/or work on
project teams Knowledge Working knowledge of ISO 9001 and/or ISO
13485 standards Working knowledge of CE and RoHS compliance
Extensive knowledge of complex capital equipment and associated
processes and testing methodologies Skilled in statistical methods
and design of experiments using Minitab Knowledge and experience in
APQP, PPAP (Applicable Part/Process Qualification Methodology).
Lean manufacturing principles and methods, including A3, poke-yoke,
value stream mapping, etc. Qualifications/Experience Technical
degree, bachelors preferred, in electro-mechanical or electrical
disciplines 3-5 years in a Quality or Test engineering role with
complex capital equipment Ability to work in a fast paced, changing
environment with minimal supervision. Work independently, establish
priorities and make decisions. Needs to be ambitious and have a
sense of urgency ABOUT RAPID MICRO BIOSYSTEMS: Rapid Micro
Biosystems creates, sells, validates, and services innovative
products for fast, accurate, and efficient detection of microbial
contamination in the manufacture of pharmaceuticals, biologics,
biotechnology products, medical devices, and personal care
products. The company's Growth Direct----the first and only
growth-based system to automate rapid compendial QC Micro
testing-ensures data integrity, compliance, and operational
efficiencies driven by rapid methods and automation. Rapid Micro
Biosystems is dedicated to providing groundbreaking technology and
products to support companies in their journey to achieve greater
reliability, efficiency, and better predictability, ultimately
providing higher quality products for improved patient outcomes.
Rapid Micro Biosystems is headquartered in Lexington,
Massachusetts.-- Our--research & development,--and
manufacturing--operations are located in Lowell, Massachusetts.
Additionally, we maintain field--offices in Freising, Germany;
Switzerland, and Singapore. Equal Opportunity: Rapid Micro
Biosystems is committed to the principle of equal employment
opportunity. Applicants for employment and employees are reviewed
on their individual qualifications for a position. Under no
circumstances will Rapid Micro Biosystems discriminate against
qualified persons on the basis of race, color, religious creed,
retaliation, national origin, ancestry, sexual orientation, gender
identity, disability, mental illness, genetics, choice of health
insurance, marital status, age, veteran status, or any other basis
prohibited under applicable law. Please no phone calls or agencies,
please.
Keywords: Rapid Micro Biosystems, Framingham , Senior Engineer, Quality, Engineering , Framingham, Massachusetts
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