Quality manager jobs in Old Bridge, NJ

Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443

Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing) • Excellent understanding of QA metrics, entry/exit criteria • Experience in Insurance or Financial services industry sector will be good to have Roles & Responsibilities • Formulate Software Quality Assurance strategy (QA and UAT) • Establish quality standards • Establish quality documentation by writing and updating quality assurance procedures • Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures • Review all the program testing deliverables across Software Testing Life Cycle (STLC) • Ensure testing deliverables completeness on test scope coverage • Ensure program testing schedule is realistic •Ensure traceability on program requirement to test cases & result • Perform root cause analysis and create pattern to identify frequently occurring defects • Arrange review finding walk-through sessions, publish detail review findings • Provide corrective actions/recommendations/best practices in reducing defect trend • Track closure of review findings and implementation of actions/recommendations • Ensure program testing risks and assumptions are clearly articulated • Create and publish program quality dashboard Thanks & Regards, Additional Information If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number. Full Name: Email: Skype id: Contact Nos.: Current Location: Open to relocate: Start Availability: Work Permit: Flexible time for INTERVIEW: Current Company: Current Rate: Expected Rate: Total IT Experience [Years]: Total US Experience [Years]: Key Skill Set: Best time to call: 2 Slots for phone interview: In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested. All your information will be kept confidential according to EEO guidelines.

Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary: This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3 rd party sanitation. Essential Job Functions: Food Safety / Regulatory Managing implementation of the HACCP Plan, its associated documents and including reassessments Maintaining records in accordance to the policy / HACCP program Conduct plant GMP inspections and monitor GMP's for compliance Responsible for maintaining the company's compliance with FSIS regulations. Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. Respond to non-compliance reports issued by FSIS. Manage the 3 rd party Sanitation program for the facility. Quality / Customer Service Lead 3 rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. Strive for continuous improvements of products, process, procedures, and reliability. Maintain data of customer requirements, quality specifications and reporting requirements. Manage quality training program. Ensure specification compliance for raw materials and finished products. Managing implementation of quality programs. Assist with product development and special projects associated with product development. Respond to customer complaints with CAPA's / letters as needed. Establish the raw material and finished product shelf life. Other Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor Manage the department to meet budget. Other tasks and projects may be assigned. 10 - 20% travel required Minimum Requirements: Red Meat Experience a Must Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. 5 plus years' experience working in the Food Industry in a leadership role. HACCP Knowledge and Experience SQF / BRC Knowledge and Experience Ability to think independently and take responsibility for decisions. What We Offer The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. Time Off: PTO, Safe & Sick Time, and Paid Holidays. Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. Financial Benefits: 401(k) + employer match and life insurance. Location: This is an on-site role located in Carlstadt, NJ. Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions · Independently conduct audits · Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits · Facilitate Sponsor health authority inspections of global clinical facilities and study sites · Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs · Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. · May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements · Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. · 5+ years of experience in GCP auditing. · Substantial experience in inspection management. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. · Demonstrated ability to operate and influence decision-making processes · Effective communication skills · Successful track record of supervising employees and managing cross-cultural differences · Technical and administrative capabilities to independently carry out routine, complex and for-cause audits · Knowledge of data integrity controls and systems quality for clinical area · Strong analytical skills and report writing skills · Experience with GxP systems including computer system validation and associated regulations, recommended. · Ability to Travel (approximately 20%) · Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Description Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness. Key Responsibilities: Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy. Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews. Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth. Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units. Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly. Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices. Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation. Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators. Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability. Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement. Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed. Qualifications: Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry. Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings. Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies. Strong working knowledge of BSA/AML/OFAC requirements. Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives. Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions. Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations. Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology. Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred. Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role. Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable. Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred. Salary: $180,000 - $210,000 K / year "Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience." About Community Federal Savings Bank (CFSB) Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy. Responsibilities Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays Supporting Management by performing peer reviews of testing data Supporting Method Performance tracking and trending through data entry, verification, and record archival Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc. Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management Support revision of SOPs and forms to improve workflows in QC Overseeing Housekeeping activities of lab areas Verifying Logbooks are reviewed on time Tracking Lab Notebooks lifecycle Working with EHS to improve Safety Culture in QC Qualifications M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry. Ability to be onsite 5 days per week Deep understanding and experience with working in a GMP environment Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays Ability to work independently and make decisions Leadership experience and project management skills to support a multi-project environment in small biotech. Physical Requirements: Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves Must be able to remain in a stationary position for 50% of the time Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens Constantly communicates verbally with people to exchange information, and give and receive instructions Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials Compensation The expected salary range for this position is $122,000 to $144,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives). EEO Statement A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

The Director of Quality Assurance & Training ensures appropriate and effective monitoring of existing procedures of program operations and delivery of services. The position also maintains an ongoing staff training program to ensure that staff are up to date on policies, procedures, and enhanced service practices. What You'll Do Create SOPs and Desk Guides for new and existing programs, reviewing and updating materials for programs and conducting training with staff to ensure understanding and compliance with both funder and Fedcap requirements. Develop and maintain an annual report that provides a thorough description of Fedcap's Quality Assurance activities with an established Quality Improvement Plan (QIP) model. Develop and implement quality assurance tools to measure and assess the impact of systems, policies and protocols on operational efficiencies and program effectiveness. Conduct site visits to observe staff interaction with participants including intakes, service plan creation, and workshops. Review case files for completeness, accuracy, and compliance. Monitor Customer Service standards including conducting participant focus groups and analyzing surveys to gather feedback and increase awareness of participants' perspective of program services. Prepare monthly and quarterly reports for Senior Leadership and regulatory bodies. Identify gaps in program and staff performance and designing and conducting staff training to cure deficiencies and reiterate company standards. Develop and conduct training programs to provide to WeCARE operations staff on various policies, procedures, and best practices. Research and continuously update training modules on various topics relevant to providing the best possible services to WeCARE participants. Assist with external audits conducted by funders and third-party auditors. Conduct safety and risk assessment to ensure compliance with ADA and regulatory standards at service locations. Work collaboratively with program departments, external agencies and stakeholders to support compliance efforts and monitor remediation (Corrective Action) activities. You're a great fit for this role if you have: A bachelor's degree in public health, public administration, human services, or a related field, with master's degree preferred. At least 2 years' experience in quality assurance, preferably in social services, public health, or workforce development. Experience with workforce development is a plus. Compensation $120,000-$130,000 The Fedcap Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. We are an EEO employer committed to diversity, M/F/D/V.

Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are now looking for a Quality Control Manager. Salary/Hourly Rate: $90k - $115k The Quality Control Manager will lead product-focused quality control operations to ensure all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel is approximately 30% to contract manufacturers nationwide. Responsibilities of the Quality Control Manager: * Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances. * Review and approve deviations, investigations, and CAPA documentation to ensure effective root-cause analysis and corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are implemented. * Manage QC laboratory operations, including equipment oversight, instrument calibration, cleanliness, and safety compliance. * Supervise the retain program and maintain product master standards. * Evaluate consumer complaint samples and support quality trend analysis. * Administer and enhance the Quality Management System (QMS), including SOPs, CAPAs, audits, inspections, and documentation. * Develop and deliver training related to cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report quality KPIs to drive continuous improvement. Required Experience/Skills for the Quality Control Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience with the ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and product release processes. * Experience working within cGMP and ISO 22716 environments. Education Requirements: * Bachelor's degree in a Scientific or Engineering discipline, or equivalent experience. Benefits: * Comprehensive medical, dental, and vision coverage (including HSA with employer contribution). * Paid time off and paid holidays. * 401(k) retirement plan. * Additional competitive benefits.

Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description Key Accountabilities: •Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives. •Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication. •Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives. •Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions. •Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements. •Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety. •Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence. •Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates. •Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions. •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies Qualifications: Minimum Requirements: This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies. When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control. •Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control. •ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance. •3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry. •Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC. •Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills. •Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment. Preferred Requirements: •ASQ certification •ISO Lead Assessor Certification •5 years plus Quality Assurance/Control •3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience). •Training in strategic planning and motivation Benefits Overview We offer competitive company benefits to eligible positions, such as : Medical, Dental, Vision Insurance Life Insurance and Disability Voluntary Wellness Programs 401(k) and RRSP programs with Company Match Paid Vacation and Holidays Tuition Reimbursement And more! Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information. Disclaimer This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information. TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers. TK does not: 1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.; 2. Request payment of any kind from prospective jobseekers or candidates for employment; 3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK; 4. Send checks to job seekers; or 5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties. PLEASE NOTE: 1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner; 2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK; 3. Anyone making an employment offer in return for money is not authorized by TK; and 4. TK reserves the right to take legal action, including criminal action, against such individuals/entities. TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. 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Job Title: Quality Manager - Food Manufacturing About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing. Oversee the quality control processes to ensure compliance with industry standards and food safety regulations. Collaborate with cross-functional teams to identify and resolve quality issues. Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements. Analyze data and reports to identify areas for improvement and implement corrective actions. Lead and mentor the quality assurance team to achieve departmental goals. Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain. Qualifications: Bachelor's degree in Food Science, Quality Management, Engineering, or a related field. Proven experience as a Quality Manager or similar role in the food manufacturing industry. Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000). Excellent analytical and problem-solving skills. Strong leadership and communication abilities. Experience with quality management software and tools. Attention to detail and a commitment to excellence. Preferred Skills: Certification in quality management or food safety (e.g., Six Sigma, CQE). Familiarity with regulatory requirements relevant to the food industry.

Job Description QUALITY MANAGER Salary: $120,000 PLUS, depending on experience Seeking a hands-on, highly experienced Quality Manager to lead and continuously improve an AS9100-certified Quality Management System within an aerospace and industrial manufacturing environment. This role requires a strong, tenured Quality leader with expert-level AS9100 experience gained in a manufacturing or job shop setting and the ability to interface confidently with leadership and external auditors. Experience in food or pharmaceutical industries not a good match for this role. REQUIREMENTS 7+ years of Quality Management experience in a manufacturing or job shop environment Demonstrated stability and strong tenure with prior employers Expert-level AS9100 experience, including hands-on ownership and audit leadership ISO 9001:2015 experience Aerospace, defense, or ITAR-regulated manufacturing background Machining experience with a strong understanding of inspection tools (calipers, micrometers, CMM, optical comparator) Excellent blueprint reading and GD&T interpretation skills Experience with PPAP, FMEA, Root Cause Analysis, and Control Plans Exposure to Environmental, Health, and Safety (EHS) standards Professional presence with the ability to interface with executive leadership and auditors Bachelor's degree preferred; equivalent experience welcomed BENEFITS Medical, dental, vision, and life insurance Paid time off, holidays, and sick time 401(k) plan Long-established, financially stable aerospace and industrial manufacturer located in Westchester County, NY.

**General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site. **Essential Functions of the Job:** + Lead the QC Physicochemistry laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. + Ensure Physicochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. + Review of laboratory test results, ensuring adherence to Good Documentation Practices. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Ensure that the QC Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience. + Working knowledge and experience with physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Strong leadership/team management skills and experience. + Manage, motivate, coach and mentor direct reports. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. + Interacts with all levels of BeOne employees + Undertake any other duties as required. **Supervisory Responsibilities:** + Manage direct reports from QC Physicochemistry laboratory. + 2+ years of managerial experience directly managing people required. + Leadership experience leading teams, projects, programs or directing the allocation of resources. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time **Travel:** Must be willing to travel approximately 10% **Education/Experience:** + Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. + Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred. + Master's degree and 4+ years of relative experience preferred. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details The Supplier Quality Manager is responsible for ensuring suppliers meet World Courier quality standards and compliance requirements while driving continuous improvement in supplier performance. This role involves developing and maintaining supplier quality programs, conducting audits, and managing supplier relationships to ensure the delivery of high-quality materials and services. The Supplier Quality Manager collaborates across departments to align supplier performance with organizational goals and regulatory standards. Primary Duties and Responsibilities: Supplier Quality Program Development * Develop and implement supplier quality management policies, procedures, and standards. * Partner with global QA to establish and maintain supplier qualification and approval processes. * Define key performance indicators (KPIs) to monitor supplier quality and performance. Supplier Audits and Assessments * Conduct regular supplier audits to ensure compliance with quality standards, regulatory requirements, and company specifications. * Perform risk assessments for suppliers and identify opportunities for improvement. * Prepare audit reports, corrective actions, and follow-up plans for supplier quality issues. Supplier Relationship Management * Build strong relationships with suppliers to foster collaboration and alignment. * Communicate quality expectations clearly and provide feedback to suppliers on performance. * Work closely with suppliers to implement corrective actions and resolve quality issues. Quality Issue Resolution * Investigate supplier-related quality issues and implement root cause analysis to prevent recurrence. * Collaborate with internal teams to address and resolve supplier-related challenges. * Ensure timely resolution of non-conformance reports (CAPA) and deviations. Compliance and Regulatory Standards * Ensure suppliers comply with industry standards, regulatory requirements, and certifications (e.g., TSA, GDP). * Maintain supplier quality documentation in accordance with company and regulatory standards. * Stay updated on changing regulations and ensure supplier compliance. Continuous Improvement Initiatives * Drive continuous improvement efforts across the supplier base to enhance quality, efficiency, and cost-effectiveness. * Partner with internal supplier management teams to reduce lead time and improve operational efficiency. * Implement best practices for supplier quality management. Required Qualifications: * Bachelor's degree in Engineering, Quality Management, Supply Chain Management, or a related field. * Minimum of 5 years of experience in supplier quality management, quality assurance, or a similar role. * Strong knowledge of quality management systems (e.g., ISO 9001, GDP). * Experience with supplier audits, corrective actions, and root cause analysis. * Proficiency in quality tools and methodologies (e.g., Six Sigma, Lean Manufacturing, FMEA, SPC). * Knowledge of regulatory requirements such as FDA, EMA, or other relevant standards. Skills and Competencies: * Excellent analytical and problem-solving skills. * Strong project management and organizational abilities. * Effective communication and interpersonal skills to collaborate with suppliers and cross-functional teams. * Ability to negotiate and influence supplier performance. * Proficient in quality management software and tools. Preferred Qualifications: * Certifications such as ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar. * Experience in pharmaceutical, medical device, or highly regulated industries. * Familiarity with ERP systems and supply chain management software. Work Environment: * Office-based with occasional travel to supplier facilities (estimated travel time 40%). * Must be able to travel overseas if required. * Requires working in cross-functional teams and engaging with suppliers globally. * Having a high sense of dedication and collaboration to support quality department's initiatives and moving quality excellence forward. * Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines. * Strong drive to remain focused, self-motivated and committed to completing or achieving tasks. * Be open minded to industry/organizations change and learn/adopt new skills/knowledge/tools to drive success. * Excellent skills in Microsoft Office (Excel, Word and PowerPoint). * Able to work independently and lead a team when required. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Salary Range* $57,900 - 85,360 * This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range. Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned . Affiliated Companies: Affiliated Companies: World Courier Inc

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Haddad is a privately held family business with 100 years' experience in the children's apparel & accessories industry. A leader in the children's wear industry, Haddad Brands is the exclusive global licensee for the most iconic brands in the world, which include Nike, Jordan, Converse, Hurley, Levi's, Polo, Abercrombie and Fitch, Lacoste, Tommy Hilfiger, Calvin Klein and Huggies. Supported by a team of professionals skilled in design, sourcing, production, sales, marketing & distribution of premium quality children's wear, Haddad distributes globally to 100+ countries and maintains sales and sourcing offices in 22 cities globally, including New York, Paris, Hilversum, Shanghai, Egypt, Bangkok, Vietnam, Sri Lanka, London and Montreal. Overview: The International Quality Manager supports global Quality Control operations by providing leadership, oversight, and coordination of product quality execution across all international regions. This role provides assistance with ensuring consistency of standards, alignment with customer requirements, and effective implementation of global QC initiatives. The manager works closely with director of quality control to strengthen overall product quality. Domestic and international travel is required. Key Accountabilities: Support global QC team initiatives by implementing company quality standards across all international regions Provide guidance to regional QC teams to ensure consistent inspector performance, inspection accuracy, and procedural compliance Partner with overseas managing offices and factory management to resolve quality issues, support corrective actions, and improve factory outgoing product quality Review and analyze global and domestic inspection reports, defect trends, and quality metrics to identify areas for improvement Visit factories as required to review production, evaluate quality risks, and verify corrective actions Communicate critical quality findings and risk assessments to the Director of Quality Control and other cross-functional leaders Support retailer chargeback prevention through compliance oversight and documentation accuracy Partner with the Director of Quality control to develop and refine global QC processes, manuals, and training materials Provide pre-production and inline quality support to factories to reduce final inspection failures Maintain consistent quality communication channels between domestic and international teams Recruit top talent, train and develop team members Special projects as assigned Requirements Required Skills/Abilities/Education: Bachelor's degree in Quality Management, Manufacturing, Engineering, or related field preferred 5-7 years of experience in Quality Control or Quality Assurance within apparel, or consumer products Strong knowledge of global manufacturing processes, inspection methods, and quality assurance systems Prior experience working with overseas factories and international QC teams Excellent communication, coaching, and cross-cultural collaboration skills Strong analytical and problem-solving abilities with attention to detail Ability to work independently across multiple regions and time zones Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) Ability to travel domestically and internationally as required Consistent in-office presence is vital to the role as it is for all Haddad Brands team members, so that we all have a full appreciation, aesthetically and tactilely, of the qualities that define our brand partners' products and set them apart from their competitors. Salary Description $80,000 - $100,000 per year

The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff. RESPONSIBILITIES Strategic Leadership & Oversight Develop, implement, and maintain a comprehensive quality control program for clinical research activities. Lead and mentor QC staff, providing guidance, training, and performance management. Serve as the subject matter expert for QC processes, regulations, and best practices. Quality Control Operations Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions). Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols. Oversee alignment of processing forms and shipping manifests with SOPs and protocols. Attend key study visits to ensure quality and compliance. Follow up on outstanding source documentation review issues with designated staff. Maintain and utilize QC tracking logs for live QC activities. Continuous Improvement & Risk Mitigation Identify non-conformances during clinical trial conduct and lead root cause analyses. Develop and implement risk mitigation strategies and corrective action plans. Drive ongoing process improvement initiatives. Training & SOP Development Lead the writing and review of clinical quality-related SOPs. Regulatory & Compliance Ensure correct IRB-approved informed consent forms and subject source documents are used. Communicate with operational departments regarding project status and issues. Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies. Strategic Planning & Vision Develop and execute the long-term vision and strategy for quality control across all clinical research programs. Align QC objectives with organizational goals and regulatory trends. Organizational Leadership Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices. Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations. Cross-Functional Collaboration Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners. Lead cross-functional committees focused on quality, compliance, and process improvement. Other Duties Perform other QC-related duties as assigned. TRAVELING Between Corporate New Jersey and New York locations, as needed. Salary Range: $85,000-$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise. Requirements Education: Bachelor's degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred. Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role. Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies. Proven leadership and team management abilities. Excellent communication, analytical, and problem-solving skills. Strong organizational and project management skills. Ability to provide accurate documentation and drive process improvements.

Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing) • Excellent understanding of QA metrics, entry/exit criteria • Experience in Insurance or Financial services industry sector will be good to have Roles & Responsibilities • Formulate Software Quality Assurance strategy (QA and UAT) • Establish quality standards • Establish quality documentation by writing and updating quality assurance procedures • Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures • Review all the program testing deliverables across Software Testing Life Cycle (STLC) • Ensure testing deliverables completeness on test scope coverage • Ensure program testing schedule is realistic •Ensure traceability on program requirement to test cases & result • Perform root cause analysis and create pattern to identify frequently occurring defects • Arrange review finding walk-through sessions, publish detail review findings • Provide corrective actions/recommendations/best practices in reducing defect trend • Track closure of review findings and implementation of actions/recommendations • Ensure program testing risks and assumptions are clearly articulated • Create and publish program quality dashboard Thanks & Regards, Additional Information If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number. Full Name: Email: Skype id: Contact Nos.: Current Location: Open to relocate: Start Availability: Work Permit: Flexible time for INTERVIEW: Current Company: Current Rate: Expected Rate: Total IT Experience [Years]: Total US Experience [Years]: Key Skill Set: Best time to call: 2 Slots for phone interview: In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested. All your information will be kept confidential according to EEO guidelines.

Job DescriptionJob Title: Quality Manager - Food Manufacturing About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing. Oversee the quality control processes to ensure compliance with industry standards and food safety regulations. Collaborate with cross-functional teams to identify and resolve quality issues. Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements. Analyze data and reports to identify areas for improvement and implement corrective actions. Lead and mentor the quality assurance team to achieve departmental goals. Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain. Qualifications: Bachelor's degree in Food Science, Quality Management, Engineering, or a related field. Proven experience as a Quality Manager or similar role in the food manufacturing industry. Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000). Excellent analytical and problem-solving skills. Strong leadership and communication abilities. Experience with quality management software and tools. Attention to detail and a commitment to excellence. Preferred Skills: Certification in quality management or food safety (e.g., Six Sigma, CQE). Familiarity with regulatory requirements relevant to the food industry.

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.