QA Manager
Company: Medpoint, LLC
Location: New Prague
Posted on: August 7, 2022
Job Description:
Medpoint is seeking candidates for this critical QA Manager
position located in New Prague, MN. This is an exciting and dynamic
organization in the life sciences industry that is seeking strong
leaders with strong background in quality, quality management
systems, and compliance. Regulated industry experience is a must,
medical device experience is preferred. POSITION SUMMARY:The
Quality Assurance (QA) Manager assists the VP of Quality and
Regulatory Compliance ensuring compliance within the company's
Quality Management Systems (QMS) adhering to all various state,
federal, and international laws/regulations that apply to business
operations. The QA Manager must coordinate with other departments
and co-workers to operate and perform critical due diligence of
processes.This position is responsible to manage and improve
processes to ensure products or services are designed and produced
to meet or exceed customer expectations and regulatory requirements
including the US Food and Drug Administration (FDA), Health Canada,
European MDD/MDR and others as required. This role will also
participate in the implementation of improvements to the company's
QMS element procedures, including Nonconformance Material
processes, Customer Complaint management, Adverse Event (AE)
reporting, Corrections and Recall handling, Corrective and
Preventive Action (CAPA) process, Inspection and other quality
assurance duties.Manages QMS processes to ensure regulatory and
internal policy compliance and continual improvement of those
processes. A strong contributor to complex projects within the
Quality and Regulatory Departments. Accountable for meeting
internal and external quality objectives. Supports Regulatory and
Operations in efforts to drive product and process improvement, as
well as the development of technical documentation to meet 3rd
party regulatory standards, including but not limited to FDA,
MDSAP/ISO 13485, and the Medical Device Regulation (MDR).
SCOPE:
- Provide leadership of the Quality Management System (QMS),
including the implementation and improvement of specific QMS
elements to ensure ongoing compliance with US FDA, EU Medical
Device Regulation (MDR), and other required regulatory
standards
- Engage in continual improvement activities by leading processes
related to CAPA, Nonconforming Material, Complaint Management, AE
reporting, Corrections and Recall handling, Change Control and
other related quality system processes
- Develop processes for the effective generation of metrics for
all QMS elements, including established Key Process Indicators
(KPI), for use within the department and upper management
- Maintain knowledge of relevant quality and regulatory standards
and augment quality system processes to meet changing requirements,
including the MDR, FDA, MDSAP and others as required
- Participates in special projects and perform other duties as
required
- Conduct periodic trend analysis and provides business impact
analysis of product and process trends to monitor and take
appropriate corrective/preventive actions to ensure product
quality, patient safety and compliance with regulatory reporting
requirements
- Supports Regulatory Affairs in their effort to achieve and
sustain compliance with regulatory standards, including FDA and
European requirements
- Assist with regulatory audits and inspections
- Participate in the gathering, development and presentation of
data that reflects the status and implementation of the QMS
- Create/draft, update and review Standard Operating Procedures
(SOPs)
- Direct and supervise daily activities of QA/QC staff involved
in receiving, in-process and final inspection, complaint
investigation, Corrective and Preventive Action (CAPA) process and
document control to ensure compliance to quality
standards/regulations.
- Manage private labeling activities (UDI, artwork review)
- Support product Safety Data Sheet (SDS) requests and
maintenance SUPERVISORY RESPONSIBILITIES:Performs supervisory
responsibilities in accordance with the organization's policies and
applicable laws. Responsibilities include training employees;
planning; assigning and directing work; evaluating performance;
addressing complaints and resolving problems.Work under minimal
supervision and may act independently to determine methods and
procedures on new assignmentsEDUCATION REQUIREMENTS: --- Bachelor's
Degree required --- Bachelor's Degree in an engineering field or
other technical science preferred. QUALIFICATIONS:
- A minimum of 10 years prior experience in Quality
Assurance
- A minimum of 5 years prior experience in Quality Assurance
Management
- Relevant training / certifications, for example, ASQ Certified
Quality Engineer (CQE) and Certified Quality Auditor (CQA)
preferred.
- Solid experience with implementation and improvement of
21CFR820 and/or MDSAP (ISO 13485) QMS elements
- Strong attention to detail
- Demonstrated experience working with regulatory bodies,
contract manufacturers, suppliers and distributors.
- Comfortable working within a fast growth and changing
environment
- Demonstrated ability to effectively communicate and influence
decision makers.
- Experience in quality systems and audits.
- Knowledge of various Quality System and Regulatory Standards
that are applicable to temperature-controlled logistics and
transportation business elements and future GMP Compliance.
- Experience working in cross functional organizations.
- Strong communication and interpersonal skills.
- Excellent written and verbal communication skills with the
ability to listen, articulate and advocate.
- Proactive, high performance result oriented and manage projects
with ethical integrity.
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when
necessary
- Demonstrate both creative and critical thinking skills
- Hold a Six Sigma Green Belt or Black Belt or willingness to
work towards attainment.
- Advanced training/experience in the use of statistical
techniques and process improvement methods.PHYSICAL DEMANDS:While
performing the duties of this job, the employee is regularly
required to stand, walk and sit. The employee frequently is
required to use hands to finger, handle or feel objects, tools or
controls and reach with hands and arms. The employee is
occasionally required to stoop, kneel, crouch or crawl. The
employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close vision
and the ability to adjust focus.WORK ENVIRONMENT: The physical
demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
Employee is frequently required to sit. While performing the duties
of this position, the employee is subject to a typical office
environment. The noise level in the work environment is usually low
to moderate.While performing the duties of this job the employee is
occasionally exposed to fumes or airborne particles.COMPETENCIES:
- Excellent independent decision making, analysis and
problem-solving skills
- Ability to plan and manage successful projects; understand
available resources, develop timeline, budget, assign tasks and
areas of responsibility
- Excellent planning and organizational skills and
techniques
- Good negotiating skills and ability to effectively manage
outsourced relationships
- Strong time management skills and the ability to prioritize
work
- Resourceful, well organized, highly dependable, efficient and
detailed oriented
- Customer service oriented and ability to work with and resolve
complex issues
- Excellent interpersonal communication skills
- Excellent written and verbal communication skills
- Excellent analytical abilities
- Oversee small projects
- Establish productive working relationships at multiple levels
within the organization
- Common business-related computer hardware and software, MS
Office. PERSONAL ATTRIBUTES:
- Passion and alignment with mission, vision, values & operating
principles.
- Desire for working in a values-based company in alignment with
a learning organization.
- A change agent and strong collaborator who is not afraid of
challenging status quo.
- An individual who brings strong core values, quality, ethics,
and integrity
- A collaborative team player who embraces and champions the
culture
- Strong work ethic and ability to deliver results and meet
commitments in a dynamic environment
- Exceptional and dynamic communications skills with the ability
to inspire and influence people at all levels, build consensus and
commitment, and effectively drive change throughout the
organization at a rate that fits the corporate culture
- Exceptional organizational and planning skills, strong
analytical abilities, and process orientation
- Desire to own decisions and take responsibility for
outcomes.
- Willingness to travel when required.
- Willingness to continually embrace personal and professional
development.PREFERRED SKILLS:
- Excellent computer skills including Microsoft office suite of
products (Word, PowerPoint, Excel, etc.)
- Understanding of GMP regulations
- Experience with IATA DG regulations, specifically Class 6.2,
Conformite Europeenne requirements, etc.
- Experience with EDMS systems and implementation.
Keywords: Medpoint, LLC, Minneapolis , QA Manager, Executive , New Prague, Minnesota
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