Quality Manager - MedTech
Company: UFP Technologies
Posted on: January 13, 2022
About UFP MedTech: UFP MedTech , a UFP Technologies, Inc
(Nasdaq:UFPT) business, offers a full suite of design, development,
process, and manufacturing services for single-use and single
patient medical devices. We create OEM devices, subassemblies,
components and packaging, from Innovation to Manufacturing, using a
differentiated flexible materials portfolio with best-in-class
operational excellence systems to improve patient outcomes for our
Our culture is centered around innovation, collaboration,
creativity, and service. This is the connective tissue that drives
our pursuit of industry leadership and customer partnerships
throughout our organization.
Summary: Reporting to the Director of Quality and Regulatory
Compliance with a dotted line to the Division Plant Manager, the
Quality Manager - MedTech plans, directs and coordinates the
development, application, and maintenance of all quality systems
for inspecting incoming product, raw material, in-process material
and products through finish product. Oversees and directs plans,
organizes and develops test plans, prepares test data and
subsequent testing of all products. Responsible for managing data
during product development and evaluation prior to product release.
Responsible for customer, ISO audits and for organizing compliance
to regulatory requirements related to manufacturing medical
Essential Duties and Responsibilities:
Develops and documents quality plans for new and existing
Monitors and controls quality systems to ensure effectiveness,
efficiency and compliance.
Analyzes quality control test results and provides feedback and
interpretation to production management or staff.
Supports manufacturing and engineering problem solving efforts on
in-process and vendor related quality issues.
Communicates quality control information to all relevant
organizational departments, outside vendors and contractors.
Investigates customer returns and complaints. Oversees development
and implementation of corrective action measures to prevent
Implements procedures to assure that products comply with customer
Coordinates, as needed, the administration of the defective
material identification & disposition program; i.e., the PMDR & MRB
Monitors & takes corrective/improvement action on key quality
measurables; i.e., parts per million (PPM), repeat complaints.
Performs or delegates the quality department functions defined in
our APQP process.
Assures control plans and checking methods and tools therein, are
meaningful and effective.
Provides training to manufacturing personnel to assist in the
preparing definition and monitoring of quality requirements.
Monitors existing business practices to ensure compliance with
existing policies and procedures (ISO compliance).
Serves as the quality management representative, representing the
quality management system to external organizations.
Supports product development and transfer into production to ensure
process capability exists and product requirements are
Participates in conducting both internal and vendor audits;
including 2 nd and 3 rd party quality system audits.
Supports purchasing in supplier performance measurement.
Oversees and directs activities of quality department staff in
support and maintenance of quality systems.
Manages individual performance providing coaching, mentoring and
performance feedback to ensure that plant objectives are achieved.
Instructs and mentors quality staff in quality control and
Generates and maintains quality operating budgets.
Develops and implements quality training programs to train
employees on the appropriate and necessary quality systems,
techniques and methods including ISO 13485 and statistical
Produces reports regarding nonconformance of products or processes,
daily production quality, root cause analyses and quality
Manages internal/external calibration of all required measurement
devices, gauges and testing equipment.
Assists other plants in assuring quality systems are in compliance,
Bachelor's degree or equivalent in quality, operations management
or engineering related field.
A minimum of 5 years experience in manufacturing with at least 2
years in a management and/or supervisory capacity.
Depending on site location, experience in an ISO environment and
ISO 9000, compliance with TS16949 and PPAP procedure.
Certified Quality Engineer (CQE or ASQ) certificate/training a
Experience in Medical Device manufacturing required.
Demonstrated ability implementing "world-class" quality management
practices to drive continuous improvement throughout the quality
Other Job-Specific Requirements:
Excellent interpersonal and communication skills (both verbal and
Strong people management and development skills.
Strong listening skills.
UFP Technologies, Inc. offers a competitive benefits package,
including but not limited to medical, dental, vision, life,
disability, 401K with a matching contribution, paid time off, paid
holidays, employee discounts and much more!
To apply for this job please create a profile with us through our
online application system. Click the "Apply" box in the upper right
hand corner to start the application process. Or, if you already
have a social media account with LinkedIn, Google, or Facebook you
can use your log in credentials to apply.
For more information on UFP MedTech, visit www.ufpmedtech.com .
UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action
Keywords: UFP Technologies, Chicopee , Quality Manager - MedTech, Executive , Chicopee, Massachusetts
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