Overview
Quality Manager Jobs in Harrison, AR at Pace Industries
SUMMARY
Ansh Labs is hiring a Regulatory Affairs & Quality Assurance Manager. The qualified candidate will serve a vital role in developing, coordinating, implementing, and maintaining quality management processes in support of the development, approval, and successful manufacture of our products in adherence to all applicable regulatory requirements and standards set forth in the company’s quality manual and standard operating procedures in accordance with customer requirements. This role will also monitor manufacturing, development, quality, and regulatory processes to ensure conformance and compliance with all FDA and applicable international regulations and execute regulatory activities according to project plans to assure new products meet submission, approval, and commercial launch goals. Related activities include compiling and writing FDA and IVDR reports as well as coordinating the completion of technical file requirements across multiple departments; and lead domestic and international regulatory and product registrations working directly with local customers and distributors.
ESSENTIAL JOB DUTIES
Quality System Management
Oversee the Company Quality Management System and Regulatory policies, procedures, and processes to ensure they are compliant to relevant requirements including, 21 CFR Part 820, IVD Directive 98/79 EC, IVDR 2017/746, as well as ISO 13485:2016 and other relevant international regulations.
Serve as the Company Quality Management Representative and Person Responsible for Regulatory Compliance (PRRC), including representing the Quality Assurance and Regulatory department on project teams and audits.
Lead, manage, and/or conduct internal, certified bodies, regulatory, customer, and third-party audits to ensure compliance with applicable regulatory governing bodies, standards, customer requirements, and procedures, including FDA, EU Notified Body and vendors.
Prepare and maintain audit documentation, including responses to findings and implementation of corrective actions.
Ensure readiness for external inspections by maintaining compliance with quality and regulatory standards.
Collaborate with cross-functional teams to address audit-related requirements and ensure continuous improvement.
Oversee the control of documents, including standard operating procedures (SOPs), manufacturing work instructions (MWIs), and product specifications.
Quality Control and Compliance
Monitor manufacturing processes to ensure consistent quality and compliance to processes and procedures as stipulated in the quality manual and in accordance with current Good Manufacturing Practices (cGMP) where applicable.
Perform and/or lead root cause analyses for non-conformance events and implement corrective and preventative (CAPA) actions.
Work closely with VION regulatory teams to ensure products meet applicable FDA, EU MDR, and other relevant standards where applicable. Manages activities associated with the Company’s CAPA, complaints, and nonconformance review processes.
Handle customer complaints by investigating root causes, collaborating with internal teams to resolve issues, and ensuring timely communication with customers.
Maintain a complaint-handling system to track, analyze, and address complaints and recurring issues effectively.
Assist in the establishment of baseline data for creation of Key Performance Indicators (KPI’s) for monitoring key quality metrics that drive continuous improvement and allow for effective means of controlling the Cost of Quality (COQ).
Regulatory Compliance
Develop and implement global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products through all phases of product life-cycle.
Provide direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control in domestic and international markets.
Drive clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of diagnostic products by relevant regulatory health authorities.
Participate in preparation, review, and approval of key IVD regulatory submissions and certifications with US and international health authorities including 510(k)s, EU Notified Body certifications, etc. Negotiate directly with relevant Quality and Regulatory authorities to obtain and to maintain product clearances.
Ensure international product distribution activities are compliant with applicable regulatory requirements.
Lead activities associated with post market surveillance, vigilance, adverse events, medical device reportable events and product recall activities, including notifications, corrections, and removals in international markets, if required.
Assess the impact of relevant regulations on IVD product development, registration, and commercialization activities.
Other duties as assigned.
Process and Product Improvement
Analyze quality data and identify trends to proactively improve processes and product quality.
Collaborate with R&D, production, and supply chain teams to address quality concerns during product development and manufacturing.
Conduct risk analysis/assessments to identify and mitigate potential quality issues.
Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities to validate processes and product designs.
Training and Support
Train staff and assure maintenance of appropriate training records and training effectiveness on quality standards, procedures, and best practices.
Coordinate management reviews and maintain recordkeeping of meeting minutes.
Maintain tech-support records and support customer inquiries by providing technical expertise and ensuring prompt resolution.
QUALIFICATIONS
Bachelors/Masters in Biotechnology/related field (life sciences, biotech engineering, chemistry).
Must be eligible to work in the United States without VISA sponsorship.
EXPERIENCE
5+ years of experience working in a Regulatory or Quality position with a minimum of 2+ years at a medical device company, preferably IVD.
Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical and life-science IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
Strong knowledge of US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDD/IVDR) is essential.
Proficient in quality compliance, such as CAPA, Root Cause Analysis, Validation, and Process Controls.
Solid scientific analytical evaluation skills.
Demonstrated communication and human relation skills.
Ability to work well within cross-functional teams.
Technical writing ability a MUST.
Proficient using Word and Excel applications and Windows operating system.
Must be able to work effectively in a fast-paced, team-oriented environment.
Ability to work independently with minimal supervision.
Demonstrated cross-functional teamwork skills.
Self-starting, detail oriented, and ability to focus on task at hand.
Well-developed English written and verbal communication skills.
Other Competencies:
Organizational Support – Follows policies and procedures; Prioritizes and plans work activities; Uses time efficiently, completing all tasks correctly and in a time manner to customer and company expectations.
Attendance/Punctuality – Is regularly at work and on time; Clearly communicates with supervisor any unfinished work responsibilities when absent; Arrives to meetings, training, and appointments on time.
Dependability – Follows instructions, responds to management direction; takes responsibility for own actions; repeatedly follows through on and meets goals/tasks set.
Quality – Demonstrates accuracy and thoroughness of job responsibilities; Looks for ways to improve and promote quality of product; Applies management direction to improve performance; Monitors own work to ensure quality that meets and/or exceeds customer and company expectations; When customer and company expectations differ, communicates and problem solves solutions with management.
Quantity – Meets productivity standards; completes work in a timely manner according to customer and/or company needs.
Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions and clearly communicates any recommended changes or improvements with management.
Adaptability – Adapts to changes in the work environment; Manages competing demands while meeting production deadlines.
Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Includes appropriate people in decision making process.
Technical Skills – Assesses own strengths and weaknesses; Strives to continuously build knowledge and skills; Shares expertise with others.
Initiative – Volunteers readily; Takes independent actions; Asks for and offers help when needed.
WORK ENVIRONMENT:
Full-time, salaried position, with benefits (Health, Dental, Vision and 401K). Work schedule: Monday-Friday; 8:30 AM – 5:30 PM.
Based in the Continental United States – Webster, Texas.
Must be willing to occasionally travel as needed.
Ability to work to stringent deadlines and manage a workload of frequent high volume and deadlines which may impose strain.
PHYSICAL DEMANDS:
While performing the duties of this Job, the employee is regularly required to:
Have the ability to remain in a stationary position 50% or greater of the time.
Have the ability to endure rigors of travel and potential disruptions to travel plans.
ABOUT ANSH LABS
Ansh Labs is a leading developer and manufacturer of tools for research and clinical diagnostics. We serve life science researchers, physician researchers, hospitals, commercial laboratories, and public health agencies to assist with research, diagnosis, treatment, and management of diseases. Ansh Labs’ core immunoassays are novel research clinical diagnostic markers with potential applications in reproductive medicine, growth disorders, metabolism, neurodegenerative disorders, oncology, etc. We excel at developing immunoassays from concept to fully validated assays. The efficiency of our monoclonal antibody development process enables us to produce and screen more antibodies to optimize pairs for a better immunoassay. Our core strength is research and development. We perform contract development and custom manufacturing services of novel immunoassays and specialty reagents for diagnostics and biotechnology research and discovery. Our products consist of emerging and maturing assays that are used by translational medicine and preclinical biomarker testing services, as well as clinical labs around the world.
Interested Candidates are encouraged to submit their resume/cv to: [email protected]
Job Type: Full-time
Pay: $80,000.00 – $120,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Work Location: In person
Title: Quality Manager
Company: Pace Industries
Location: Harrison, AR
