Quality assurance manager jobs in Plainsboro, NJ - 265 jobs

Prysmian is the world leader in the energy and telecom cable systems industry. Each year Prysmian manufacturers thousands of miles of underground and submarine cables and systems for power transmission and distribution, as well as medium low voltage cables for the construction and infrastructure sectors. We also produce a comprehensive range of optical fibers, copper cables and connectivity for voice, video, and data transmission for the telecommunication sector. We are 30,000 employees, across 50+ countries. Everyone at Prysmian has the potential to make their mark; because whatever you do, wherever you are based, you will be part of a company that is helping transform the world around us. Make Your Mark at Prysmian! Accountable to the Director of Quality and Operations Manager, the Quality Manager position is responsible for Prysmian Downhole Technology and Oil and Gas quality operations within North America. The position is a senior technical professional for all aspects of PDT and Oil and Gas product lines. The Quality Manager also assures that all products conform to the applicable specifications and quality levels established by Prysmian and the customer. As part of the Bridgewater Management Team, the Quality Manager is also responsible for ensuring the plant meets its stated business objectives and maintains the plant's ISO 9001 QMS. The Quality Manager will serve as support for Huston and Taunton with respect to PDT and Oil & Gas needs. Responsibilities include the following: Developing and implementing quality control standards, processes, and controls. Reviewing and approving methods for inspection, testing, sampling, and training. Evaluating production capabilities through quality KPIs. Recommending and implementing improvements wherever necessary. Directs the implementation and maintenance of the Quality System Supports the Safety and Environmental Management System. Interaction with customers on various product, application, and technical nuances of the oil and gas, and downhole market(s). Interacting with North America HQ personnel for periodic information exchanges. Interact with the Taunton team as needed for product quality and customer service of the PDT and OGP product lines. Provides effective communication to internal and external customers on matters relating to quality. Our Quality Team Values These Skills: Ability to understand the technical needs of customers and communicate Skilled at interacting with all levels of the organization, excellent communication skills, and inter-personal skills. Skilled at leading cross functionally and motivating direct reports. Experienced problem solver and engage with customers, vendors, and end users. Quality Tools for analysis and problem solving Metrological knowledge Proficient in understanding ISO 9001. Awareness of ISO 14001 and ISO 45001. Knowledge of auditing methodologies, validation protocols, design verification and validation protocols, Risk assessment and mitigation processes. Qualifications: Bachelor's degree in a technical discipline (required). Engineering is preferred. At least 5 years of experience managing in a manufacturing facility required. Ability to understand the technical needs of customers and communicate Internal nonconformities management Preferred: Ability to interpret, understand and apply operational specifications and standards, Hydraulic fluid cleanliness standards, Welding requirements and standards (e.g., ASME BPVC Section IX), Electrical communication and power transmission, Fiber optic sensor technologies and communication protocols, Oil industry operational specifications and standards, and API Q1 & Q2. Sound computer skills, comfortable with a variety of software applications Wire and cable experience a plus Six Sigma certification a plus ASQ Certification a plus Prysmian, as an Equal Opportunity Employer, aims to attract and recruit individuals with diverse backgrounds, skills, and abilities. We strongly believe that diversity brings significant value at all levels of the organization, increasing the possibility of capturing market opportunities and maximizing value for our customers and stakeholders. With Diversity, Equity, and Inclusion (DE&I) as part of our Social Ambition 2030 and a strategic pillar of our Company culture, Prysmian is committed to the development of an organization that prioritizes talent, where people feel respected, included, and free to fully express their potential just as they are. All Managers and HRs in Prysmian are responsible for ensuring DE&I policies are respected during the recruiting process, as well as recognizing and mitigating unconscious biases that must not influence our selection processes. All persons will be considered for employment without regard to their race, ethnicity, religion, nationality, origin, citizenship status, socio-economic status, age, sex, gender identity or expression, sexual orientation, marital status, disability, military service or veteran status, pregnancy, parental leave, medical conditions, or any other characteristic protected by applicable federal, state or local laws. Prysmian will endeavor to make a reasonable accommodation for any disclosed physical or neurological condition or disability of a qualified applicant unless the accommodation would impose an undue hardship on the operation of our business. Visit our DE&I Page to learn more about Prysmian's commitments. Your application data will be treated according to our Data Protection Policy. If you believe you require assistance to complete this form or to participate in an interview, please contact us at [email protected]. English_formattedESQA508c.pdf

Eaton's Light Safety division is currently seeking a Quality Manager. This role is located out of Long Branch NJ. The expected annual salary range for this role is $107,800 - $158,125 a year. Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations. The Quality Manager will be responsible to formulate, implement and administer Eaton's Quality Management System (EQMS) and strategic initiatives to achieve short and long range quality improvement objectives. Driving focus will be on the reduction of warranty and customer concerns along with improving internal quality performance and driving continuous improvement. In Additions to Quality Manager responsibilities the incumbent will have EHS function responsibilities. What you'll do: • Manage the quality function and direct reports to meet plant quality objectives and drive the quality culture with the leadership team • Lead the timely response to customer concerns • Deploy "I own Quality" culture to reduce internal and external DPPM • Lead cross-functional teams to effectively introduce New Products to full production. • Understand and adhere to EQMS to ensure compliance with ISO 9001, customer specific requirements, and all regulatory requirements • Review daily in-process metrics to determine team priorities • Deploy 5S and foster/expand 5S culture • Interact with divisional resources to improve product quality • Develop internal product validation methods to ensure process quality consistency • Drive employee engagement in continuous improvement and lean manufacturing practices • Lead the quality team utilizing the Eaton Leadership Model to effectively communicate requirements and expectations • Leads and supports team to facilitate risk assessments to identify critical EHS hazards. Works with leadership team to create targets and objectives based on key EHS risks • Determines appropriate leading and lagging indicators to track performance against targets and objectives • Supports EHS goals to drive EHS culture, compliance, and results • Assigns MESH element champions and facilitates their ownership of and development in the MESH elements • Facilitates annual MESH self-assessments and corporate MESH assessments every three years • Drives and promotes zero incident EHS culture throughout site • Creates EHS engagement through employee involvement in EHS teams (Safety, Ergonomic, First Aid, etc.) • Works with leadership team and MESH champions to complete regular compliance evaluations and checks of federal, state, and local regulations • Uses established EHS data processes such as MESH PRISM and Benchmark to manage data such as injuries and illnesses, environmental metrics, risk assessments, EHS actions and other pertinent information • Creates training matrices to ensure that all training is defined and tracked to completion • Ensures that all key EHS operational controls are in place, on a PM program, and that EHS action items are resolved on a timely basis • Leads monthly divisional report outs on EHS related goals, actions and culture development Qualifications: Basic Qualifications: • Bachelor's degree in Engineering from an accredited institution required • Minimum of 3 years of combined experience in manufacturing or quality • Thorough experience with ISO9001 • Must be legally authorized to work in the United States without company sponsorship • No relocation benefit is offered. Candidates must reside within 50 miles of Long Branch, NJ. Active Duty Military is exempt from this geographical location Preferred Qualifications: • Experience and knowledge of ERP systems (preferably SAP) • Experience with Lean Six Sigma • Certification by the American Society for Quality as Six Sigma Black Belt or Certified • Quality Engineer • EHS Experience We are committed to ensuring equal employment opportunities for job applicants and employees. Our recruitment processes use balanced selection criteria and avoid unlawful discrimination against applicants on the basis of their age, colour, disability, marital status, national origin, gender, gender identity, genetic information, race or racial origin, religion, sexual orientation or any other status protected or required by law.

Job Title: QA Document Coordinator Duties: Assist with adminstrative activities including but not limited to: Proper labeling of all documents (2250+) documents in and entering document Archive Room Logbook generation and issuance Support shipping of documents offsite to Iron Mountain (secure GMP facility for documents) and ensure all documents are scanned prior to shipment Other administrative duties as needed Skills: Exceptional organization and time management skills Strong attention to detail with the ability to work accurately in a busy and demanding environment Ability to successfuly work within strict timelines Excellent work ethic Education: Minimum Associates Degree

LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law. A little about us... Role: Tandem Certification/Testing Lead Location: Atlanta, GA/Berkeley heights, NJ Job Description: Tandem Certification Lead 8-10 years of experience in banking and cards domain Deep understanding of Credit Card Switch Authorization platforms and the flow Knowledge on ISO 8583 message formats and fields Experience in Testing on Tandem Base 24 platform Experience in scheme certification with Visa MC Amex is good to have Good analytical skills to be able to debug issues during merchant certification Experience in using ICC tool is good to have Very good communication skill for handling external client communications Skills Mandatory Skills : Card Acquiring Domain LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.

Job Title: Microbiology, Manager The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. This individual serves as the subject matter expert on contamination control and microbiological testing of parenteral drug products. The role involves significant participation in customer and regulatory audits, client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams. Essential Duties and Responsibilities: Develop and maintain leader standard work in the laboratory Align and maintain staff shift schedules with required manufacturing support functions Demonstrate expertise in CGMP guidelines, ISO 17025, and USP microbiological testing, especially USP , , , , , and Maintain laboratory policy and procedure manuals; assist in developing and validating procedures and document preparation Ensure timely completion of projects, CAPAs, and investigations Manage, conduct, and/or delegate the final review and approval of environmental and microbiological test results, including those from contract labs, to support lot disposition and deliverables as prioritized by site leadership Oversee compliance guideline reviews, industry trend assessments, customer projects (method transfer, development, etc.), validation efforts, expansion projects, and continuous improvement initiatives Act as SME to lead collaboration between departments to trend and continuously improve site Contamination Control Strategy and Environmental Monitoring Program Represent the department during regulatory, customer, and internal audits; ensure timely response to audit observations and execution of related CAPAs Develop and execute training on laboratory methods, instrumentation, and aseptic technique Build and evolve the department Training Matrix to align with industry standards and best practices Write and revise Microbiology and other relevant SOPs as required Provide technical input on product testing issues and instrumentation/equipment Ensure laboratory compliance with cGMP through inspections of monitoring systems and equipment Ensure proper recording and review of data Test the integrity of raw materials or finished products Conduct and document failure and complaint investigations Serve as liaison to service, calibration, and technical representatives Facilitate revision and release of controlled documents Facilitate mandatory reviews of SOPs and month-end reports Provide oversight for projects to update/maintain official document templates Direct and manage the Change Control System Read and interpret SOPs to ensure compliance Maintain up-to-date training records Perform other duties as assigned Education and/or Experience: Bachelor's Degree in Microbiology or related field Minimum of five (5) years of experience in microbiology or related field within a GMP-regulated environment Minimum of two (2) years of experience in a microbiology leadership role Previous experience with pharmaceutical cleanroom environments Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements Preferred Experience: Five (5) years of experience in a microbiology leadership role Five (5) years of microbiology laboratory experience within a GMP-regulated setting Supervisory Responsibilities: This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. It also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives. Language Skills: The ideal candidate should have the ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills are essential, along with effective presentation skills to successfully present information and respond to questions from managers, clients, customers, and the general public.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

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.

About Us QISG leverages Quanta's comprehensive resources to deliver collaborative solutions for our partners' energy infrastructure needs. We use in-house talent, expertise and resources to plan, design, engineer, manage, conduct maintenance on and construct projects. Our turnkey service capabilities provide our customers with efficiency, consistency, attention to detail and safe execution. The QISG team brings together Engineering, Safety, Quality, Material Procurement, QA/QC, Right-of-Way Acquisition, Scheduling, Environmental Planning, Permitting, Title and Land Management expertise that ensure outstanding results for our clients. About this Role The Field Quality Manger at Quanta Infrastructure Solutions Group (QISG) will be responsible for monitoring and auditing a project's quality management requirements and executing the Project Quality Management Plan. This position collaborates closely with Project Managers and other stakeholders to oversee project quality objectives and activities. The QA Manager leads the planning and surveillance of procured equipment and materials, assisting the Director of Quality in measuring Quality Management System processes. This is a full-time, on-site role based in Linden, New Jersey. What You'll Do TYPICAL RESPONSIBILITIES Develop and review planning for quality requirements of projects, including identifying the appropriate standards, guidelines, and checklists for the project Develop and/or update project-specific audit plans, including schedule, documentation, and resource requirements Monitor the performance of the Sub-contractor for compliance with quality requirements. Assist Business Development and Marketing leads in developing quality-related deliverables for pursuits and new opportunities Create project-specific quality management plans during the planning stage of a project Provide guidance in the execution of the Quality Management System Lead changes and improvements in performance and process plans Offer leadership, support, and guidance for project-specific quality management activities Interact with Quanta Operating Units to provide guidance on contract-required quality obligations, requirements, and documentation Lead the project team in quality-related training and awareness regarding planned activities Monitor the alignment of project procedures and processes with the Quality Management System and project contract requirements Verify that lessons learned, corrective action items, and improvement measures for project requirements are completed Recommend procedural improvements and best practices based on audit results/experiences and lessons learned Plan and execute systematic and independent examinations/audits of project quality requirements, objectives, and documentation Identify and document issues that may cause or contribute to deviations from planned/expected outcomes and develop corrective action plans to address these issues Assist the Directors of Operations with maintaining the overall Quality Management System for activities specific to procedures, processes, and training Regularly interact with field operations and project management teams, corporate Operations Support, Project Controls teams, and clients regarding quality-related matters Perform detailed inspection/audit reviews of each feature of work within the definable features of work Perform random inspections of work performed by Quanta Operating Units and subcontractors; review QA documents as they are issued Review Quanta Operating Units or subcontractor procedures and quality records to verify compliance Manage document control as it relates to quality; verify that project documents used at the job site are updated, maintained, and stored in accordance with project procedures. This includes design drawings, supplier and subcontractor drawings, test records, etc. Manage Non-Conformance Control; verify that non-conformances are identified, documented, tracked, and resolved by the PM and the Site CM acceptably Adhere to internal standards, policies, and procedures Perform special projects and complete other duties as assigned or requested What You'll Bring REQUIRED EXPERIENCE AND EDUCATION Bachelor's degree in a relevant field, or an equivalent combination of education, training, and experience 30-hour OSHA certification CIA - Certified Internal Auditor CQA - Certified Professional Auditor Certifications involving inspection, testing, welding inspection, structural bolting, testing, and commissioning Minimum of ten (10) years' experience in various aspects of design, surveillance monitoring, and Project Management, including: Experienced in electrical and substation, mechanical, and piping construction, as well as facility startup and operations Must have heavy mechanical process piping background Full understanding of ASME codes Full understanding of Hydrotesting, pneumatic testing and mechanical startup process Quality Inspections/Audits of Engineering and/or other Projects Successful development and implementation of a Quality program, including all necessary processes and procedures Experience as a Manager, Superintendent, Project Manager, or Quality Manager/Auditor on projects Experience working in multiple states and understanding state and local codes relating to quality Experience meeting Local AHJ requirements Strong background or familiarity with safety requirements on projects Strong understanding of environmental considerations Leadership and inspection experience in surveillance oversight programs Developing inspection test plans for monitoring/observation programs for surveillance of project or program specified manufacturer's equipment and materials Technical expertise related to design and related requirements Testing, standards compliance, etc. Thorough understanding of equipment and material specifications and testing requirements employed at manufacturer facilities Technical expertise in implementing Inspection and Testing programs Solid understanding of critical path scheduling Excellent problem-solving skills Strong attention to detail Strong organizational and planning skills Excellent communication skills with strong interpersonal skills Ability to work alone as well as in a team environment TRAVEL REQUIREMENTS Travel: Yes Percent of Time: 100% What You'll Get Competitive Compensation 401(k) Retirement Plan Holiday Pay Paid Time Off (PTO) Comprehensive Health Coverage Pet Insurance Employee Assistance Program (EAP) Professional Development Tuition Assistance Employee Discount Program Compensation Range The anticipated compensation for this position is USD $140,000.00/Yr. - USD $160,000.00/Yr. depending on experience and qualifications. Equal Opportunity Employer All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, national origin or ancestry, sex (including gender, pregnancy, sexual orientation, and/or gender identity), age, disability, genetic information, veteran status, and/or any other basis protected by applicable federal, state or local law. We are an Equal Opportunity Employer, including disability and protected veteran status. We prohibit all types of discrimination and are committed to providing access and equal opportunity for individuals with disabilities. For additional information or if reasonable accommodation is needed to participate in the job application, interview, or hiring processes or to perform the essential functions of a position, please contact us the Company's Human Resources department.

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.

**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.

OPEN JOB: Quality Manager - Manufacturing / EHS / 3 rd Party Agency Audits SALARY: $100,000 to $150,000 INDUSTRY: Manufacturing & Production JOB CATEGORY: Manufacturing - Quality IDEAL CANDIDATE Experience Managing 3rd party external agency audits EHS experience Our client's Light Safety division is currently seeking a Quality Manager. This role is located out of Long Branch NJ. The Quality Manager will be responsible to formulate, implement and administer Quality Management System (EQMS) and strategic initiatives to achieve short and long range quality improvement objectives. Driving focus will be on the reduction of warranty and customer concerns along with improving internal quality performance and driving continuous improvement. In Additions to Quality Manager responsibilities the incumbent will have EHS function responsibilities. What you'll do: Manage the quality function and direct reports to meet plant quality objectives and drive the quality culture with the leadership team Lead the timely response to customer concerns Deploy “I own Quality” culture to reduce internal and external DPPM Lead cross-functional teams to effectively introduce New Products to full production. Understand and adhere to EQMS to ensure compliance with ISO 9001, customer specific requirements, and all regulatory requirements Review daily in-process metrics to determine team priorities Deploy 5S and foster/expand 5S culture Interact with divisional resources to improve product quality Develop internal product validation methods to ensure process quality consistency Drive employee engagement in continuous improvement and lean manufacturing practices Lead the quality team utilizing the Leadership Model to effectively communicate requirements and expectations Leads and supports team to facilitate risk assessments to identify critical EHS hazards. Works with leadership team to create targets and objectives based on key EHS risks Determines appropriate leading and lagging indicators to track performance against targets and objectives Supports EHS goals to drive EHS culture, compliance, and results Assigns MESH element champions and facilitates their ownership of and development in the MESH elements Facilitates annual MESH self-assessments and corporate MESH assessments every three years Drives and promotes zero incident EHS culture throughout site Creates EHS engagement through employee involvement in EHS teams (Safety, Ergonomic, First Aid, etc.) Works with leadership team and MESH champions to complete regular compliance evaluations and checks of federal, state, and local regulations Uses established EHS data processes such as MESH PRISM and Benchmark to manage data such as injuries and illnesses, environmental metrics, risk assessments, EHS actions and other pertinent information Creates training matrices to ensure that all training is defined and tracked to completion Ensures that all key EHS operational controls are in place, on a PM program, and that EHS action items are resolved on a timely basis Leads monthly divisional report outs on EHS related goals, actions and culture development Basic Qualifications: Bachelor's degree in Engineering from an accredited institution required Minimum of 3 years of combined experience in manufacturing or quality Thorough experience with ISO9001 Must be legally authorized to work in the United States without company sponsorship No relocation benefit is offered. Candidates must reside within 50 miles of Long Branch, NJ. Preferred Qualifications: Experience and knowledge of ERP systems (preferably SAP) Experience with Lean Six Sigma Certification by the American Society for Quality as Six Sigma Black Belt or Certified Quality Engineer EHS Experience If you are interested in pursuing this opportunity, please respond back and include the following: MS WORD Resume required compensation. Contact information. Availability Upon receipt, one of our managers will contact you to discuss the position in full detail. STEPHEN FLEISCHNER Recruiting Manager INTERMEDIA GROUP, INC. EMAIL: *******************************

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. Please visit our official careers website at ******************************** to view authentic job openings at TK. If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************. We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.

Quality Manager (Manufacturing | Quality & EHS) Industry: Manufacturing & Production Function: Quality Management / EHS Employment Type: Full-Time Compensation: $120,000 - $140,000 base (dependent on experience) Travel: Occasional Relocation: Not available (candidates must be local) About the Role: We are seeking a Quality Manager to lead plant-level Quality Management Systems (QMS) while also owning key Environmental, Health & Safety (EHS) responsibilities. This role is responsible for driving a strong quality ownership culture, reducing customer and warranty concerns, improving internal quality performance, and embedding continuous improvement across operations. This is a hands-on leadership role within a safety-critical manufacturing environment. The Quality Manager partners closely with site leadership, operations, and cross-functional teams to ensure quality and EHS systems are effective, compliant, and fully integrated into daily operations. Key Responsibilities: Quality Leadership Lead and manage the quality function and direct reports to meet plant quality objectives Implement and administer a plant-level Quality Management System aligned with ISO 9001 Lead timely investigation and response to customer concerns and quality escapes Drive reduction in internal and external defects (DPPM) through root cause and corrective actions Support New Product Introduction (NPI) through cross-functional quality readiness Review daily quality metrics and set priorities for the quality team Develop and improve internal validation and inspection methods Deploy and sustain 5S and continuous improvement practices Lead third-party, customer, and regulatory audits EHS Leadership Own and support site EHS programs, risk assessments, and compliance activities Promote a strong zero-incident safety culture through employee engagement Identify leading and lagging EHS indicators and track performance against goals Support regulatory compliance with federal, state, and local EHS requirements Ensure training matrices are defined, tracked, and completed Lead EHS reporting, assessments, and continuous improvement initiatives What We're Looking For: Required Qualifications Bachelor's degree in Engineering or related technical discipline 3+ years of combined experience in manufacturing and/or quality Strong working knowledge of ISO 9001 quality systems Experience managing third-party or external audits Hands-on experience in a manufacturing plant environment Authorization to work in the U.S. (no sponsorship available) Ability to work on-site; candidates must live within commuting distance Preferred Qualifications Experience with ERP systems (SAP preferred) Lean Six Sigma experience or certification ASQ certification (Six Sigma Black Belt, CQE, or similar) Prior Quality Engineer or Quality Manager experience Practical EHS leadership experience What This Role Is (and Is Not) This role is: Plant-based and operations-focused Leadership-oriented with hands-on execution Focused on quality culture, metrics, and continuous improvement Integrated with EHS and safety accountability This role is not: A documentation-only or audit-only quality role A remote or hybrid position Limited to inspection or customer complaints alone What Success Looks Like: Reduced customer complaints, warranty issues, and internal defects Strong audit performance and sustained ISO compliance Engaged employees who take ownership of quality and safety Clear quality and EHS metrics tied to plant performance Visible leadership presence on the floor If you are a manufacturing quality leader who thrives in plant environments, values safety, and enjoys driving real operational improvement, we encourage you to apply. Equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Full-time Description SS White Burs is a leading dental device manufacturer that strives to bring high quality dental products to market, enabling practitioners to work more efficiently and to maximize patient comfort and quality. The creation of unique and differentiated products is the cornerstone of SS White Dental. Our footprint has been around for 170 years and makes us one of the most well recognized and trusted names in the industry today. Requirements Manages Customer complaints (RMA: Return Material Authorization): · Receive and organize return product for RMA process · RMA processing which involves receipt/system transaction and proper disposition of material in Epicor as per Procedure PROSP9 · Perform needed testing of product according to complaint and as per Work Instruction WISP901. · Recording of evaluation results for quality complaints · Physical movement/disposition of product · Proper closeout of customer complaints in Epicor · Closeout DMRs generated for quality related complaints Calibration: · Manage calibration program which includes monthly calibration schedule, maintaining calibration records, calibration results entry in GageTrak and conduct calibration inspection when needed as per procedure PROSP5. · Schedule calibration for outsourced calibration equipment which includes obtaining quotes from vendor, completing internal purchase requisition to get Purchase Order from Purchasing Department. Other responsibilities and functions: · Generate and issue COC (Certificate of Compliance) and COA (Certificate of Analysis) as requested by Customer and according to Shipping Pick list · Assist with File Heat Treating as needed · Manage set-up bin (in Epicor and physical inventory) Qualifications: · High school diploma or equivalent · Proficiency using Microsoft Office and other Windows based applications · Demonstrated ability to read, write legibly, and understand English · Highly organized & detail orientated · Ability to communicate and work with all departments and all levels of management

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

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.

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.

Job Description Come work for a great company at APluscare! The Quality assurance Coordinator is responsible for preserving the standard of the services of the agency. Quality assurance personnel are accountable for assisting to create and execute quality control and management methods and systems. Personnel are accountable for monitoring that the services of the agency meet the standard and are error free. Job Duties: The principal responsibility of quality assurance personnel is to make sure quality of the services provided by APluscare is at the highest level. Quality assurance employees must review the business statistics and then determine areas requiring enhancement. A quality assurance employee should also inspect the samples and formulate policies concerning improvement of the present quality standards. Personnel should ensure that the services take place in accordance with the standards established. Additional responsibilities include all other duties as assigned by APluscare. The Quality Assurance Coordinator is required to: Oversee and ensure agency's compliance with DDD regulations at all levels of operations. Demonstrate broad knowledge of New Jersey Division of Developmental Disabilities (DDD) and Department of Human Services (DHS) licensing standards, regulations, and circulars. Maintain agency's residential/other programs compliance with DDD, DHS, Medicaid, and other applicable state and federal regulations. Cooperate and coordinate with state and other relevant officials during investigations of incidents that involve APluscare and/or its personnel. Ensure agency's compliance with applicable federal and state laws, regulations, and licensing requirements. Ensure agency's compliance with applicable accrediting bodies. Suggest and participate in policy and procedure development, modification, renewal, as well as adherence while maintaining compliance with applicable requirements. Provide weekly training and In-service to all staff involved in providing services and supports to clients of APluscare. Conduct weekly visits and audits of all DDD licensed programs in order to maintain continuous compliance with DDD licensing standards. Identify program deficiencies for all residential programs on a weekly basis and supervise program staff as needed to correct deficiencies. Maintain DDD licensure renewal for all agency programs that are licensed by the division. Maintains all company vehicles including registration, insurance, preventative maintenance, repairs, and equipment inventory according to APluscare policies and licensing standards. Maintains all licenses/certificates for each APluscare program and prepares homes on a regular basis and for licensing inspections. Prepare new programs for initial DDD licensing inspection and secure licensure. Maintain continuous program integrity for all agency programs through quality assurance surveys and reviews. Track and report on quality-related indicators, including areas of risk management and compliance. Conduct weekly quality assurance surveys for all DDD licensed programs Maintain agency compliance with all local, state, and federal regulations for all agency programs Conduct monthly visits and audits of all residential and other programs Prepare and submit program integrity and quality assurance weekly report to the Executive Director Identify program deficiencies for all residential and other programs on a monthly basis and supervise program staff as needed to correct deficiencies All other duties as assigned by APluscare Qualifications: The Quality Assurance Coordinator is expected to posse s excellent interpersonal skills, including the ability to communicate effectively with in individuals with intellectual and developmental disabilities and their families, colleagues, and other parties as necessary for employment with APluscare. Outstanding negotiation skills, customer-oriented approach, excellent analytical skills, effective leadership capability to lead projects, fundamental knowledge of operational software and understanding concerning concepts, equipment and various other quality management techniques. Employee must cooperate with the officer of licensing and/or any department of Human Service staff in any inspection or investigation Employee must successfully complete and demonstrate proficiency in all areas of required training. Valid Driver's License Must be at least 18 years of age Physical Demands/Working Conditions: Handles detailed, basic to complex, and specialized concepts and problems, balancing multiple tasks simultaneously. The ability to effectively communicate (orally and written) and interact with others, including diverse, interdisciplinary, cross-functional teams The ability to read, concentrate and learn Physical requirements include sitting, standing, walking, and computer work for long periods of time Pushing, pulling, and lifting up to 50lbs Driving and travel locally and between agency sites and other required locations Support and maintain all corporate policies, procedures, and quality and confidentiality standards Duties and responsibilities may be added, deleted or changed to meet the needs of the organization