Director Of Design Quality Assurance Jobs

Experience with quality management systems (SQF, ISO, HACCP, GMP, etc.).

Embrace the opportunity to be a valued member of the management team and grow professionally as the company grows.

Contribute significantly to company goals through the support of a small, highly competent management team.

Bachelor's or Master's degree in Food Science, Food Technology, Microbiology, Quality Management, or related field.

Minimum of ten years of progressive experience in quality assurance and quality control within the food manufacturing industry.

Strong understanding of food safety regulations, standards, and compliance requirements.

2.2 At least 3 years management experience in a biotech industry

2.7 Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.

2.9 Strong interpersonal skills, with experience in leading high-performance team and cross functional projects.

1.7 Ensure the validation programs and SOPs are properly established and they meet regulatory requirements.

2.3 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections

2.4 Experience in establishing and improving quality systems.

Participate in and provide QA direction in development program planning and management meetings.

Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience

Manage QA consultants and other external vendors, including organizing and prioritizing group tasks, performing training; expand QA department, as needed.

12+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Strong interpersonal, communication, teamwork, and analytical skills

Excellent leadership and people management skills, with the ability to inspire and motivate teams toward achieving common quality goals

Establish and maintain robust quality management systems, processes, and procedures to ensure compliance with applicable regulations, guidelines, and standards

Deep understanding of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, etc.), and quality management systems

Lead and manage a team of quality assurance professionals, providing guidance, coaching, and performance evaluations

Stay abreast of evolving regulatory requirements and industry trends to proactively identify opportunities for process improvement and innovation

Foster a culture of quality and continuous improvement by organising training programs, workshops, and knowledge-sharing initiatives

Bachelor's Degree in engineering, business, or construction management. Relevant work experience is also to be considered as an alternative.

Oversee the preparation and control of project-specific quality system management documentation prior to project commencement.

Manages quality assurance staff job results by coaching, counseling, and disciplining employees.

10+ years of construction QA/QC experience, preferably in solar, civil, or utility infrastructure projects

Assures quality products and processes by establishing and enforcing quality standards and testing procedures for materials and products.

Preparation of QA manual control and supervision of all amendments and revisions.

Responsible for the design, deployment & support of CLS's Engineering Quality Management System (QMS) for ATS Engineering Services.

Manage Design/Engineering Services internal Quality audit program and manage Customer/Agency audits for as required-working with the Quality/Engineering teams within Eng. Services.

Conduct Partner Design Quality assessments (working with an outsource team). Monitor, Audit and support Qualification and then drive Supplier Quality organization.

General knowledge of an electronic manufacturing environment, materials, manufacturing and business processes.

Excellent analytical, negotiation and problem resolution skills.

Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production within tight time deadlines.

Strong knowledge of quality management principles, methodologies, and frameworks (e.g., Six Sigma, Lean, ISO standards).

Guide the leadership team in the integration and management of a world class QMS for Pura products and processes.

Adept at communicating up. Communication skills coach for junior team members.

Strong problem-solving abilities, root cause analysis, and attention to detail.

Implement ISO 9000 (or equivalent QMS) companywide.

Develop and implement a quality production program to ensure conformity of purchased material and final products to quality standards.

Ensures adherence to change management process and support validation activities such as development of user requirements, protocols and reports.

Leads Quarterly Management Reviews with the executive team.

Ability to make risk-based and phase appropriate decisions and effectively communicate risks to management.

Leads internal audits, customer audits as well as surveillance and certification audits by our notified body to ensure compliance.

Strong verbal and written communication skills and ability to navigate stakeholders from various departments.

Requires knowledge of ISO 9001 and/or ISO 13485, 21 CFR 820, or ICH Q7.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

Knowledge of industry accreditation and ICF/IID standards as well as state licensure requirements and agency policies and procedures.

Coordinate annual review and update of agency policies and procedures to ensure compliance with all standards for accreditation, certification, and licensure.

Coordination of agency record-keeping systems to ensure compliance with all required accreditation, licensure, and certification standards.

Development and implementation of systems to assure compliance with licensing requirements.

Ability to plan, organize, implement and evaluate complex administrative responsibilities.

Support effective management of the QA process and related continuous improvements

12+ years of quality assurance experience

Proven leadership experience managing large, diverse global teams

BA/BS degree or equivalent work experience required

Financial acumen with experience managing own budget

Experience in a customer service environment or related position

3 years of experience in management of QA organization including management of third parties that are also delivering QA services.

Ensure that management and allocation of QA resources based on project needs is performed.

Develop and/or lead change management efforts across all phases of projects and initiatives to drive the Firm's culture of continuous improvement.

Establish relationship and governance with internal and third-party team members to conduct Quality Assurance responsibilities.

Oversee and manage a global QA team with diverse backgrounds supporting QA development, which may include one or more third-party organizations.

Bachelor's degree in Computer Science, Computer Engineering, Information Technology or equivalent experience.

5-10 years of experience in quality for HCT/Ps and/or medical devices

Bachelor’s Degree in a biological science or related field required

** Candidates MUST be US Citizen or Green Card Holder - No C2C or Sponsorship Available **

Recruit and manage a highly functional and motivated QA team.

BS or MS Degree in Computer Science, Information Science or related with equivalent experience

Experience leading quality and test engineering functions for large-scale products/services across server, web/SaaS, desktop, and mobile platforms

Experience with test automation and frameworks

Experience recruiting, leading and developing high-quality teams that produce results

Very strong communication skills, including an ability to communicate effectively to technical and non-technical stakeholders

Associates at Eurest are offered many fantastic benefits.

Must have F& B experience

Must have USDA and FDA experience

• Experienced in prepared foods manufacturing a plus.

• HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must.

• Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice.

Demonstrated successful experience as a Quality Assurance Director or equivalent in a nonprofit, government, or other clinical setting

Demonstrated planning and organizational skills

Superb written and oral communication skills

Hybrid work model - 3 days from home

Conduct and ensure compliance with all contractual, regulatory, and ethical obligations of the agency

Lead preparation and execution of all external and internal program audit activities (CARF, County, Medi-cal etc)

Demonstrated skills in project management and working with vendors and contractors.

Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.

Ideally 5 years of experience in leading the Quality Assurance function, preferably at the Director/Senior Manager level.

Minimum of 5 years related Quality Assurance experience in the Pharmaceutical/Biopharmaceutical/Biotechnology or Consumer Goods industry

Solid experience working within US and EMA GMPs.

Experience interacting with and responding to US and other Health Authorities.

Serves as the primary quality assurance resource for problem identification, resolution, and continuous improvement.

Instructs quality assurance personnel on quality control and analytical procedures.

Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer.

Performs root-cause analysis and other problem-solving activities regarding nonconformance of products and processes to identify effective corrective actions and process improvements.

Communicates quality issues, trends and losses to all relevant organizational departments.

Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

Work Experience/Requirements for This Role

Valid driver's license. SQF Practitioner or equivalent GFSI scheme experience, HACCP Certified (as appropriate)

Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security

Direct Employee Training of FSQA Programs, Policies, and Procedures

Direct Recall and Traceability Programs including Mock Recalls

Direct Independent FSQA Audit Program - SQF Audits

Working knowledge of USDA, FDA and GFSI requirements

Client offer a base plus bonus pay structure with strong benefits and paid time off

8 + years of related Quality Assurance experience in the food industry

5+ years of experience leading a team of both direct and indirect reports

Strong knowledge of HACCP, food safety, and SQF documentation, processes, and programs

Experience with Continuous Improvement programs and LEAN Manufacturing

Working knowledge of quality risk management concepts

Internal trend analysis of audit observations; identifies and communicates to QA management all compliance risks

Ensures that the GCP Vendor Audit Schedule is created and approved by management

Experience auditing GCP vendors, internal GCP processes and documents and clinical investigator sites

Extensive knowledge and/or awareness of ICH GCP regulations and guidance for clinical and nonclinical development.

Knowledge of global regulatory standards and associated guidance’s/guidelines