Quality Assurance Manager
Company: Grey Search + Strategy
Location: Burnsville
Posted on: June 20, 2022
Job Description:
ABOUT THE COMPANY:Our client is a leading manufacturing,
marketer and supplier of pharmacy supplies and consumer goods based
in the Twin Cities South Metro, with several manufacturing and
vendor partners in the U.S. and internationally. They have many
trusted brands in the marketplace and function as an omni-channel
company selling products wherever consumers shop. The company's
caring culture and values ensure they have a lot of fun while
performing at a high level.ABOUT YOU:The Quality Assurance Manager
is accountable for developing, implementing, coaching, and
executing on the our client's QMS with a hands-on approach. You
will provide leadership to the Quality Assurance team, and consider
their site affiliations (United States, Hong Kong, United Kingdom,
Netherlands) when deploying QMS systems and controls. You will also
support the Regulatory Affairs team on periodic needs to meet
regulatory and customer requirements. With a mix of strategic and
tactical responsibilities, this opportunity will allow you to
expand your skill sets and see results of your efforts
real-time.RESPONSIBILITIES:
- Provide hands-on assistance and leadership in the effective
day-to-day implementation and functioning of the QMS at the
Burnsville and other affiliated facilities; Coordinate and track
internal and external audits and inspections, third-party product
testing, investigating customer complaints, control of
nonconforming product, training and QMS metrics and management
reviews
- Perform critical analysis of quality data to identify any
trends or patterns of problems that require corrective or
preventive action, including internal audits, complaints,
nonconforming product and supplier quality metrics
- Monitor GMP practices in the production and warehouse areas
through audits and walk-through reviews to ensure that these meet
regulatory and procedural requirements; report on findings and
actions to correct any anomalies
- Oversee the effective implementation, validation and operation
of the Grand Avenue eQMS modules.
- Supervise the QC Inspectors and Document Control Specialist,
and the development and optimization of work practices, systems and
procedures
- Ensure that incoming products and materials are inspected and
dispositioned correctly; determine inspection criteria, create and
implement function test methods, establish the inspection criteria
and sampling plans to ensure products meet specified requirements
and customer expectations
- Investigate customer product issues and third-party test
facilities; work with other company functions to identify/implement
effective solutions; keep customers informed of the status and
outcomes
- Develop product quality plans for new and existing products,
identifying critical-to-quality attributes and controls to ensure
that the product meets its intended performance specifications
- Assist with the validation of new/changed products in
accordance with specified requirements and applicable inspection
criteria
- Coordinate product testing to meet regulatory and customer
specification/contractual requirements
- Participates in risk analysis and risk reviews on products and
processes
- Support Regulatory Affairs with activities relating to
demonstrating compliance with government and product related
regulations
- Lead by example by following company policies, standards and
specifications to ensure effective consistent administration of
practices, procedures and policies
- Directly manage employees to ensure effective staff planning,
selection, retention, development, disciplinary action and
performance management; conduct regular team meetings
- Stays abreast of the team member climate/culture to ensure
solutions to problems are developed while issues are minor;
collaborate with V.P. of Quality & Regulatory and Human Resources
on employee relations issues, including but not limited to
discipline and development
- Provide back-up to quality inspectors and Document Control
SpecialistEDUCATION + EXPERIENCE
- Bachelor's degree or equivalent in a technical or engineering
discipline
- At least five years of quality management system and compliance
leadership experience in a regulated industry
- Leadership of a quality and compliance team
- Internal auditing or ASQ certification a plus
- Working knowledge of the Consumer Product Safety Commission
requirements is a significant advantageSKILLS + ATTRIBUTES
- In-depth knowledge and practical application of FDA 21 CFR Part
820 Quality System Regulation, Good Manufacturing Practice for
Medical Devices, and ISO 13485: 2016
- Ability to problem-solve and conduct thorough investigations
into formulating root cause and developing and implementing
practical and cost effective solutions
- Detail oriented, organized, and capable of working effectively
with minimum supervision
- Ability to work effectively with cross-functional staff and in
a team
- Ability to communicate and work effectively with internal
employees and external stakeholders, including customers, suppliers
and regulatory bodies
- Possess an understanding of quality-related principles, tools
and techniques
- Working knowledge of MS Office -- Willingness to continuously
learn and be open to feedback
- Verified personal and professional values aligning with
APL
- Willingness to work overtime as needed, and be able to work
well under deadlines
Keywords: Grey Search + Strategy, Burnsville , Quality Assurance Manager, Executive , Burnsville, Minnesota
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