Quality Systems Complaints Specialist Job at MillenniumSoft Inc (Sparks, MD)

Quality Systems Specialist

The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufactu...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree or equivalent experience in Science or related field
post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
experience in dealing with Regulatory Compliance desired
good problem solving and investigation skills would be beneficial
an ability to work in a dynamic, fast-paced and goal driven environment
be dedicated
meticulous in attention to professional standards
good professional standards and demonstrates good attention to detail
ability to work under pressure and meet deadlines
highly motivated self-starter and team worker

Job Responsibility

Ensure the compilation of Quality Management Review process
review and approval of process change controls, SOPs, NCRs and CAPAs
implementation, execution and administration of Change Control System and NCR System
administration of Recall process with the Quality management team
administration/co-ordination of risk assessments
support facility projects including process development and quality improvement initiatives
manage and maintain the Documentation System
manage site archive, storage, retrieval and destruction processes
review and approval of Quality documentation
assist in the collation of information and preparation of reports for Annual Product reviews

What we offer

Pension
Health Insurance
Life Assurance
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Quality Specialist

As a Quality Specialist, you will play a central role in managing the food safet...

Location

Belgium , Antwerp

Salary:

Not provided

AXEREAL SCA

Expiration Date

Until further notice

Requirements

Master/Bachelor Degree in a food science or related discipline, or equivalent in-role experience
Speak and write Dutch and English fluently
Experience in or passion for the food production sector, preferably malting or brewing
Relevant experience in quality, malting or brewing
Knowledge of HACCP, food safety and quality systems within the food or drinks industry (preferably FSSC 22000)
Think and work in an analytical and structured way
Strong sense of perseverance and follow up on issues until they are fully resolved
Like thinking out of the box and coming up with innovative ideas and solutions
Have a driver license

Job Responsibility

Support the Quality Manager to ensure that your sites comply with Group Quality, food and feed safety policies and standards
Prepare and own the internal audit and inspection plan for the sites within the cluster and provide support on external audits
Investigate non-conformities and implement preventive and corrective actions to ensure zero food safety incidents (from audits or customer complaints)
Provide relevant support and training in areas such as understanding Quality, food safety and hygiene and assist in management of relevant documentation

What we offer

Attractive salary and benefits package
Career opportunities internationally
Focus on flexibility, inclusion, collaboration and health and wellbeing

Fulltime

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications

Location

United States , Fort Pierce

Salary:

Not provided

Assessfirst

Expiration Date

Until further notice

Requirements

High school diploma, GED or equivalent required
Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required
Strong verbal and written communication skills
Must have above average problem-solving and decision-making abilities
Proficiency with computers
Must have explicit attention to detail
Must have excellent analytical skills, organization skills, and follow-up
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Use hands to handle or feel objects, tools, or controls

Job Responsibility

Perform donor record file review
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
Review medical reports and communication
Perform reviews of equipment incidents
Verification and release of sample shipment
Responsible for the inspection and release of incoming supplies
Initiate deviation reports as needed
Perform Weekly employee observations
Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
Reviews the documentation of unsuitable test results and the disposition of the associated units

Fulltime

Quality Assurance Packaging Specialist

This position within the QA department provides Quality oversight, support and k...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Degree or 3rd level qualification (Science, Quality)
Demonstrated experience in packaging as the Quality contact for the area
Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role
Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels
Strong organizational skills, including ability to follow assignments through to completion
Proficiency in PC skills such as Excel, Word, PowerPoint
Proven decision making capability with full accountability and responsibility
Demonstrated coaching skills

Job Responsibility

Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs)
Provide Quality direction and oversight of the development of new and existing processes in the packaging area to meet customer needs
Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections within the packaging area of operations
Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely
Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements
Minimising impact to packaging operations on site
Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements
Review and release inputs for use in manufacturing as required
Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies

Fulltime

Quality System Specialist 2

Under the direction of the Complaints Management, the Quality System Specialist ...

Location

United States , San Antonio

Salary:

28.00 - 30.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum 1+ years of experience with Medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations
Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker
Knowledge of product failure modes
Ability to work with customer system administrators and clinicians
Proven ability to maintain a professional demeanor when handling complex user issues and high pressure situations
Expert level knowledge of the Complaints handling system
Proven ability to multi-task and seamlessly move between business unit platforms
Ability to take ownership and think independently, with minimal supervision

Job Responsibility

Manage activities and procedures associated with complaints concerning BD products including reviewing customer complaints and potentially filing the Medical Device Reports (MDR’s) associated with complaints to the FDA
Processing of product complaints including but not limited to customer communication (e.g. Email’s, phone calls) and interacting with health care workers, consumers and other professionals regarding their product quality concerns
Maintenance of complaint files and responses to customers
Create final letters and or review for accuracy to ensure that all customers’ requirements have been met
Escalation of quality issues, in order to get resolution and or Business responses for the customer
Manage the process of the complaint handling system including, receipt of complaints from all sources and all in process steps including data entry
Routing the complaint to appropriate location for further evaluation
Entering of the complaint into the complaint handling system
Checking for complaint accuracy and content, correct information to process the complaint
Follow procedures to ensure timely and accurate review of customer complaints and filing of MDRs with the FDA

Fulltime

Complaint Handling Management Specialist

Complaint Handling Management Specialist for a Medical Device Company. Primary r...

Location

United States , San Antonio

Salary:

24.00 - 28.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum 1+ years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian Regulations
Ability to work with customers, system administrators, and clinicians
Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations
Expert level knowledge of the Complaints handling system
Proven ability to multi-task and seamlessly move between business unit platforms
Ability to take ownership and think independently, with minimal supervision
General knowledge of producing metrics and building reports
Strong analytical, deductive reasoning and listening skills

Job Responsibility

Medical Device Product Complaint Handling
Medical Device Reporting (FDA)
Manage intake and reporting of the product complaint handling process including, receipt of complaints from all sources (including Service Cases and Work Orders) and all in process steps complaint determination, Data entry, Critical Thinking to request additional information (as needed), reportability decisions, MDR filing, and serve as point of contact for customer communication
Routing the complaint to appropriate location for further evaluation
Entering of the complaint into the complaint handling system
Checking for complaint accuracy and content, correct information to process the complaint
Provide training to personnel involved in overall complaint process as directed by management
Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved
Maintains annually competencies through training and documentation of training
Contact the customer or vendor for further information or follow up

Fulltime

Quality Assurance Manager - CLIA/CAP Laboratory

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cu...

Location

United States , Pleasanton

Salary:

132800.00 - 179600.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
Demonstrated experience building or expanding quality systems in a CLIA lab setting
Strong working knowledge of CLIA / CAP quality and documentation requirements
Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
Experience preparing for and leading CAP inspections and CLIA audits
Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
Experience with LIMS, electronic QMS tools, and training management systems is required

Job Responsibility

Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
Act as quality liaison with external auditors and partners

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

Quality Systems Complaints Specialist

MillenniumSoft Inc

Location:
United States , Sparks, MD ▼
San Antonio, TEXAS

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 11, 2026

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Quality Systems Complaints Specialist

MillenniumSoft Inc

Location:United States , Sparks, MD ▼San Antonio, TEXAS

Category:Quality Control

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 11, 2026

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Job Posted:
January 11, 2026