Quality Control Inspector jobs at Medical Billing

So why join Hologic? You will have the opportunity to get in on the ground floor at a high growth facility to create a manufacturing process working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance you manufacturing operation skills and knowledge to further your career. The Quality Control Inspector is a critical member of the Quality Assurance team, responsible for ensuring that finished products and in-process components meet all regulatory, quality, and customer requirements before release to inventory. This role involves the meticulous review of Device History Records (DHRs), performing inspections, and providing support to manufacturing and quality processes, such as Incoming Inspection, Material Review Board (MRB), Calibration and Returned Material Authorization (RMA) activities. The Final Inspector 2 is instrumental in upholding Hologic's commitment to excellence by ensuring compliance with Good Manufacturing Practices (GMP), ISO standards, and quality systems, while fostering a culture of continuous improvement and collaboration. What to expect: * Lead with Ownership - Demonstrate integrity and always aim to do the right thing. Be highly accountable for your work, follow through on commitments, and take responsibility when things don't go as planned. Embrace opportunities to try new things and learn from mistakes. * Act with Speed - Approach tasks with a strong sense of urgency and a bias toward action. Keep stakeholders informed by providing regular updates early and often, ensuring transparency and avoiding unexpected surprises, even when working at a fast pace. * Foster Partnerships - Collaborate effectively with teammates and stakeholders to achieve shared goals. Invest in building strong working relationships and contribute to efforts that fulfill the organization's Purpose, Promise, and Passion. * Delight Customers - Strive to exceed expectations by delivering high-quality work, exceptional experiences, and innovative solutions. Engage in proactive communication, provide excellent service, and develop a deep understanding of customer needs to create positive, lasting impressions and build trust-based relationships. * Celebrate WINS! - Take pride in delivering impactful results. Contribute to a positive team environment by celebrating both individual and team accomplishments. Support colleagues, recognize collective successes, and embody the mindset of an 'A-player' who inspires others. What we expect: * Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards. * Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements. * Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product * Lifecycle Management (PLM) system, including identification, quarantine, and documentation. * Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities. * Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards. * Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP). * Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics. * Collaborate with Engineering to provide feedback on documentation improvements and process changes. * Support Incoming, product returns and calibration teams as needed as needed. * Perform other duties as assigned by leadership to meet organizational and operational needs. Education and Experience: High school degree and/or an equivalent technical school education preferred. Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment. Experience with Oracle, and Agile preferred. The annualized base salary range for this hourly role is $46,100-$69,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

RESPONSIBILITIES is responsible for, but not limited to, the following: With minimal supervision, performs intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product, in process assembly and/or final inspection. Conducts batch record review and release, including review of NCMR's, deviations etc., Interprets route tickets, quality inspection documents and deciphers quality expectations for the product. Selects proper AQL samples and reporting inspection and testing data. Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training, and safety (equipment, associate, and material) Performs and documents results of inspections per company procedures. Ensures that all work assignments meet corporate quality and regulatory requirements Recommends activities to promote continuous improvement and best practices Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position will not have management responsibilities. PHYSICAL ATTRIBUTES Clean Room environment Ability to lift up to 25 pounds Ability to stand for long periods of time MINIMUM QUALIFICATIONS High School Diploma 3+ year of Quality Control Experience in Medical Device Manufacturing. OR Equivalent job experience with additional training in the trade; or equivalent combination of education and experience Understanding of a quality management system (QMS) and cGMP knowledge PREFERRED QUALIFICATIONS Must possess intermediate math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator Ability to read, interpret, and understand drawings, blueprints, and specifications Knowledge of clean room operations a plus Detail oriented and follows instructions and specifications meticulously. Must be able to accurately fill out paperwork as required. Intermediate computer knowledge. Flexible and able to work in a fast-paced, dynamic environment Demonstrated ability to read and write English with ability to follow written instructions or procedures. Strong verbal and written communication skills. Knowledge of inspection tools such as rulers, calipers, or gauges Team oriented with a demonstrated interpersonal skills and positive attitude Ability to independently manage time efficiently Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. ******************* TransMedics is committed to equitable and transparent compensation. The compensation for this role is a fixed rate of $30.00 (hourly), based on our good-faith determination. Actual compensation is non-negotiable and not subject to variation. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability 401K PlanPet insurance Employee Stock Purchase Plan TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

**Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :12967 Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. **OEM -** Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. **Position Summary** This position is responsible for performing product inspections and testing, implementing controls, standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and requirements are being followed. **Principal Responsibilities** With direction of the Quality Technician Lead, this position assists with - Performing inspections and laboratory tests as assigned - Addressing product quality issues and non-conformances - Support process compliance and related documentation - Daily production support - Participate in continuous improvement projects Specific responsibilities include: - Incoming, in-process, and final inspections - Material testing, analysis, and documentation of results - Analyze Data: Review and analyze data from inspections or tests to identify trends or areas for improvement. - Identification of non-compliances (product or process) via creation of nonconformances using (NC) process - First article inspections and product/process validation activities - Perform creation and inspection of product identification labels - Support document control activities (Agile updates, work package validation & storage) - Perform IV lab tests - Support customer complaint investigation activities - Perform Device History Record review and product release activities in SAP - Provides and communicates accurate information and test data to Production or Engineering upon request. - Maintain Equipment: Ensure that testing and inspection equipment is calibrated and maintained. - Troubleshoot Issues: Identify quality issues and collaborate with the team to troubleshoot and resolve them. - Ensure Compliance: Adhere to all safety, regulatory, and quality standards in all tasks. - Additional responsibilities may be assigned to support daily Quality department or production activities. - Follow safety, manufacturing and QA procedures and requirements **Education / Experience Requirements** - Minimum of a High School Diploma or equivalent required - Minimum of 2 Years working as a technician or equivalent - Knowledge and experience of working in the medical device industry preferred - Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired - Experience in Lean/Six Sigma techniques preferred - Six Sigma Green Belt or ASQ Certification desired - Strong analytical & problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred) - Previous participation in 5S events & FMEAs preferred - SAP/ERP system experience preferred **Specialized Skills / Other Requirements** - Proficiency in reading and interpreting engineering drawings, specifications, dimensioning & tolerances, procedures and documentation. - Proficiency in use and understanding of measurement & test equipment including an understanding of Gage R&R process. - Excellent attention to detail, math, analytical and problem-solving skills. - Proficient computer skills in Microsoft Office required. - Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality. - Must possess excellent communication skills, both verbal & written. - Must be able to interface directly with employees & internal Teleflex suppliers. "Hands-on" approach towards manufacturing floor involvement. - Experience with GDP, and ISO Quality Systems, is strongly desired - Ability to work in fast paced, team-oriented work environment. - Knowledge of validation processes highly preferred. - Ability to work as part of an effective team The pay range for this position at commencement of employment is expected to be between $21.25-29.75 per hour however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. _At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************._ _Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._ _© 2025 Teleflex Incorporated. All rights reserved._

Expected Travel: Up to 10% Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. Position Summary This position is responsible for performing product inspections and testing, implementing controls, standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and requirements are being followed. Principal Responsibilities With direction of the Quality Technician Lead, this position assists with * Performing inspections and laboratory tests as assigned * Addressing product quality issues and non-conformances * Support process compliance and related documentation * Daily production support * Participate in continuous improvement projects Specific responsibilities include: * Incoming, in-process, and final inspections * Material testing, analysis, and documentation of results * Analyze Data: Review and analyze data from inspections or tests to identify trends or areas for improvement. * Identification of non-compliances (product or process) via creation of nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification labels * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests * Support customer complaint investigation activities * Perform Device History Record review and product release activities in SAP * Provides and communicates accurate information and test data to Production or Engineering upon request. * Maintain Equipment: Ensure that testing and inspection equipment is calibrated and maintained. * Troubleshoot Issues: Identify quality issues and collaborate with the team to troubleshoot and resolve them. * Ensure Compliance: Adhere to all safety, regulatory, and quality standards in all tasks. * Additional responsibilities may be assigned to support daily Quality department or production activities. * Follow safety, manufacturing and QA procedures and requirements Education / Experience Requirements * Minimum of a High School Diploma or equivalent required * Minimum of 2 Years working as a technician or equivalent * Knowledge and experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired * Experience in Lean/Six Sigma techniques preferred * Six Sigma Green Belt or ASQ Certification desired * Strong analytical & problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred) * Previous participation in 5S events & FMEAs preferred * SAP/ERP system experience preferred Specialized Skills / Other Requirements * Proficiency in reading and interpreting engineering drawings, specifications, dimensioning & tolerances, procedures and documentation. * Proficiency in use and understanding of measurement & test equipment including an understanding of Gage R&R process. * Excellent attention to detail, math, analytical and problem-solving skills. * Proficient computer skills in Microsoft Office required. * Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality. * Must possess excellent communication skills, both verbal & written. * Must be able to interface directly with employees & internal Teleflex suppliers. "Hands-on" approach towards manufacturing floor involvement. * Experience with GDP, and ISO Quality Systems, is strongly desired * Ability to work in fast paced, team-oriented work environment. * Knowledge of validation processes highly preferred. * Ability to work as part of an effective team The pay range for this position at commencement of employment is expected to be between $21.25-29.75 per hour however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ************ or *******************. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. 2025 Teleflex Incorporated. All rights reserved.

Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory Review MPS of other incoming inspectors for approval and release. Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation Perform OOS investigations and participate in MRB as required for rejected materials Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel Perform biennial review for designated procedures and MPS as needed Documents; author and complete DCR as required Document all work activities according to Good Documentation Practices Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: Associates degree in the life science or relevant work experience 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: Bachelor's degree preferred Experience working in a clean room environment Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

As a QA Laboratory Technologist III, you will evaluate materials and products to ensure they meet our high quality standards. You will work within a team to perform a broad range of laboratory work requiring application of professional judgment, perform specialized studies and/or specific assignments within the Product Quality Laboratory. Responsibilities include validations, reliability testing, functional testing, proficiency survey testing and general housekeeping. General laboratory tasks include: inventory management, data analysis, calibration and maintenance, quality control and laboratory testing. Responsibilities Key Accountabilities Responsible for the execution of: Reliability Testing, GEM Functional Testing, GEM Prescreen Testing, Value Assignment for Werfen products, Proficiency Testing, Validation Activities, and etc. Ability to interpret clinical proficiency survey results of difficult complexity. Performs calibration coordination: maintain accurate calibration records in SAP, lead potential out-of-tolerance equipment investigations, train staff, and execution of calibration and maintenance for laboratory equipment. Maintains inventory of laboratory supplies, reagents, and other consumables. Monitors proper storage conditions and expiration dates are maintained. Train other QA Laboratorians and Medical Technologists on protocols, techniques, and project specific studies. Participate in cross-functional meetings to present data, may involve slide creation, presentations, and maintain detailed and accurate records. Responsible for Proficiency Survey scheduling including meetings and shipments. Manage data for survey results, calibrations, Reliability and Functional testings and other studies. Other duties as directed by the Manager/designee. Networking/ Key relationships Work with various functional groups throughout the organization including other Werfen sites. Qualifications Minimum Knowledge & Experience required for the position: Bachelor's Degree in science related field or Medical Technology. Medical Technologist Preferred. Five years or 2 years (with a Master's) of clinical laboratory experience. Lean and Six Sigma certification is a plus. Skills & Capabilities: Expert knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practices (GWP), and Product Quality Escalation. Knowledge of equipment calibration, maintenance processes, and techniques. Excellent oral and written communications, problem solving, statistical knowledge. Proficient in MS office applications particularly Excel, Work and PP. Minitab and Power BI is a plus. Ability to work safely and efficiently in a busy biohazardous laboratory environment. Reliable and dependable. Ability to lift and move materials per current OSHA standards. Travel requirements: N/A

PURPOSE: Work as part of the Quality Assurance Team to ensure the highest quality product in compliance with internal procedures, cGMP's 21 CFR 820 and ISO 13485. GENERAL RESPONSIBILITIES: Inspection of finished product to meet internal procedures and customer requirements Level 1 and 2 inspection of raw materials per applicable material specifications. Write and revise procedures as necessary. Assist with audits (customer, FDA, and ISO) in the knowledge area of inspection activities. Ensure non-conforming material is handled per applicable procedure. Ensure quarantine areas are orderly and items are properly labeled to its status, when applicable. Ensure timely trending of inspection data. Product label verification per applicable procedures. Inspection of kits using ANSI/ASQZ1.4-2003 and applicable procedures. Quality assurance review of quality records (i.e. charts, and other associated quality records). Other duties as assigned. KNOWLEDGE AND SKILL REQUIREMENTS: Use of Microsoft Word, Excel and Microsoft Outlook Experience in performing quality inspections. Slight lifting may be required. EDUCATION AND EXPERIENCE: High school diploma and two years inspection experience or the equivalent combination of experience and/or education required. GENERAL COMPETENCIES: Adapts to change, open to new ideas and responsibilities. Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record. Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback. Communicates well (written and verbal). Good listener, committed to finding solutions to problems, works well with difficult people. Manages workload, works efficiently, and meets goals and objectives. Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services;compliant with quality system requirements. Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner. PHYSICAL REQUIREMENTS: Occasionally sit, constantly stand and walk, constantly use hands to finger, handle, or feel. Constantly reach with hands or arms, frequently climb or balance, occasionally stoop, kneel, crouch, or crawl. Constantly talk or listen, occasionally taste or smell. Lift 11 to 25 lbs. 1-33% of the time, carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to working near moving mechanical parts. Frequently exposed to fumes or airborne particles or toxic or caustic chemicals. Moderate noise is typical for the work environment of this job. SALARY: $49,000-$50,000 BENEFITS: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Professional development assistance Referral program Tuition reimbursement Vision insurance

Performs inspection and monitoring of all incoming materials that require inspection, including but not limited to packaging, chemicals, subassemblies, mechanical and electrical components. They are inspected in accordance with FDA/GMP requirements and established company SOPs and specifications. Responsibilities Key Accountabilities: Performs professional work requiring application of general and specialized methods, tests, procedures, techniques and instruments as detailed in departmental SOPs. Inspects materials and products, for conformance to specifications, using fixed or preset measuring instruments and/or analysis of vendor supplied documentation. Normally will work under a condition of limited supervision. Ensures materials and products are in accordance with established tolerance levels for quality and performance and are not irregular or damaged. Works with QA, Tech Support and Buyers on a limited basis to resolve, NCRs and other discrepancies. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks, not limited to inspections. Abilities to be developed at this level for advancement purposes are initiative, follow-up, facilitation, evaluation in detail and responsibility. Primary job functions typically require exercising some independent judgment. Works independently. Placement of Bar Code labels on all in-coming material and use of Bar code reader. All responsibilities required for Inspector I. Data entry of transactions and inspections into SAP. Displays working knowledge in primary inspection responsibility. At direction of Supervisor or Manager will perform special assignments as necessary Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Grasps basic Quality Control theories and techniques and ability to implement them. Qualifications Minimum Knowledge & Experience Required for the Position: High School diploma or equivalent with at least 2 years in a Quality Control or Inspection experience. Basic understanding of GD&T and good knowledge of quality control principles. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. International Mobility Required: No Travel Requirements: No The annual base salary range for this role is currently $low range to $high range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

The Quality Technician is a hands-on, contract role supporting the inspection, documentation, and quality assurance of medical devices during early-stage R&D builds. This position plays a critical role in ensuring product integrity and compliance by performing detailed inspections, maintaining accurate records, and collaborating with cross-functional teams to uphold quality standards throughout the development process. The ideal candidate is detail-oriented, methodical, and committed to maintaining high standards in a fast-paced, collaborative environment. Experience in regulated industries, especially medical devices, is highly valued. Responsibilities: Conduct in-process and final inspections of small, intricate components and assemblies Review and interpret engineering drawings, specifications, and quality documentation to ensure compliance Record inspection results, deviations, and observations with precision and clarity Maintain accurate and organized documentation in accordance with GMP and ISO 13485 standards Collaborate with engineers to identify and resolve quality issues, and perform root cause analysis and investigation activities Assist in the documenting non-conformances and contributing to root cause analysis and corrective actions Ensure adherence to cleanroom protocols and quality control procedures during all build activities Key Decision Rights: Escalate quality concerns, deviations, and non-conformances Provide input on inspection criteria, documentation practices, and process improvements Required Skills and Competencies: Strong attention to detail and ability to perform precise inspections under magnification Familiarity with quality control principles and documentation practices in a regulated environment Ability to interpret technical drawings, specifications, and inspection criteria Ability to follow detailed instructions and maintain focus on repetitive tasks Strong communication skills and willingness to ask questions and learn Familiarity with basic computer tools for data entry and documentation Experience working in a regulated manufacturing or R&D environment preferred Education and Experience: High School Diploma or equivalent required Minimum 3 years of experience in a quality, manufacturing, or assembly tech/operator role Experience in medical device or cleanroom environments is a plus Additional Information: Role is based in Acton, MA and requires on-site presence 5 days per week. Cleanroom gowning and adherence to GMP/ISO standards may be required Note: This role may include a 3 to 6-month rotation through Insulet's Global Manufacturing Engineering (GME) organization according to project needs. During this time, the candidate will gain hands-on experience across multiple teams, build cross-functional relationships, and develop a strong understanding of Omnipod assembly and system-level function. After the rotation period, the engineer will transition into a dedicated NPI project team. NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $25.00 - $37.75 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation 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. (Know Your Rights)

This position ensures the compliance of the controlled equipment system, both calibration and day to day maintenance of equipment. Duties include the review calibration and preventative maintenance reports, entering calibration data and schedule routine calibration of new and existing equipment. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Maintain the electronic equipment scheduling database. Issue new equipment asset numbers and maintain history of calibration and PM events. Create and maintain calibration folders Review, approve and maintain calibration and preventative maintenance reports Distribute calibration and PM schedules and past due reports Schedule external suppliers for offsite and onsite calibration and PM Maintain proper identification and status of equipment Perform other TransMedics tasks and duties as assigned/required. PHYSICAL ATTRIBUTES Physical Activities: Mobility: Walking, standing, sitting, balancing, stooping, kneeling, crouching, reaching, pushing/pulling, lifting, carrying. Fine Motor Skills: Grasping, fine manipulation, feeling. Sensory Abilities: Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus. Hearing: Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions. Other Senses: Ability to perceive smells, tastes, or textures as relevant to the job. Environmental Factors: Temperature: Exposure to hot or cold environments. Noise: Exposure to loud or distracting noises. Hazards: Exposure to chemicals, machinery, or other potential dangers. Other Considerations: Repetitive Tasks: Frequency and duration of repetitive movements. Mental/Emotional Demands: Stress levels, ability to handle change (tasks, workload). Equipment Use: Ability to operate specific tools or machinery. Safety: Ability to work safely and follow safety procedures. MINIMUM QUALIFICATIONS 1-3 years experience in equipment calibration, calibration management and/or calibration system software Experience in controlled or cleanroom manufacturing environment and ESD controls Strong math and basic statistical skills (mean, std. dev., distributions) PREFERRED QUALIFICATIONS Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred. Strong computer skills (Microsoft office, Access, MES or other database software) Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously. Excellent interpersonal skills, excellent written and oral communication skills. Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. ******************* Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability 401K PlanPet insurance Employee Stock Purchase Plan TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

The Operations Quality Technician will be a critical contributor in a mission that truly represents a once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people. The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be trained in performing Incoming, In-process inspections in the cleanroom, or assessing the final product's efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment. Responsibilities: • Inspect and record results of work on Incoming raw material, In-process, or Lot Qualification at various stages of the production process, distribution process to determine and maintain the quality and reliability of our product. • Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example - Word, Excel, SAP, Electronic DHR systems, Oracle Agile, and others). • Generate, review, and maintain quality records in support of the Quality System. (For example - device history records and training records) • Ensure the equipment calibration status is within the timeframe of use. • Assist the Quality Manager in notified body and regulatory authority audits and inspections. • Works from specifications, work plans, procedures, and general instructions from either Quality Engineers, Quality Supervisor, or the Quality Manager. • Required to maintain and enforce cGMPs. • Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs). • Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times. • Maintain a clean work environment suitable for medical device manufacturing and cleanroom production. • Performs other duties as required Education and Experience: Minimum Requirements: • High School diploma Required Core Competencies: • Excels at the organization and maintenance records accurately. • Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment. • Must be proficient in English language to be able to read documentation, communicate, and write. • Mathematics - Basic mathematics skills (adding, subtracting, multiplying, dividing) • Autonomy - Capable of working independently with minimal instruction from their supervisor. • Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products preferred, not required. • Experience working in a lab setting environment in the medical device industry preferred, but not required. • The ability to use stereoscopes and varying microscope setups preferred, but not required. Physical Requirements: • Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift. • Required to reach above shoulder frequently and below waist occasionally. • Required to push and pull. • Ability to lift up to 50lbs occasionally, 5-20lbs frequently. • Vision capability to inspect small parts/components/labeling (Corrective lenses allowed) *Would like to add a test component to ensure that candidates can successfully utilize the microscopes from a vision perspective. NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $19.00 - $28.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation 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. (Know Your Rights)

About Us We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: This position is a Sunday - Thursday shift with initial training occurring Mon-Fri for approx. 6 months before transitioning to the Sunday - Thursday requirement. Occasional holiday hours may be required to maintain ongoing cell cultures. The QC Analyst III performs advanced quality activities in support of product production and releases with minimal supervision. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. This position also requires repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time. Occasional Class 10K gowning is required to support QC activities. How You Will Achieve It: * Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing. * Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and assay development/optimization. * Interact and coordinate with Manufacturing and QA Operations daily. * Coordination of test sample receipt and scheduling. * Execute assigned tasks with minimal supervision. * Donated tissue receipt and transfer. * Identify and report areas for process improvement. * Generate and execute feasibility/validation protocols. * Generate trend reports as they relate to quality testing. * Work closely with team members to ensure timely release of materials. * Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations. * Revise/Create SOPs. Job Requirements What You Need to Achieve It: * Bachelor's degree in Biology or related field, with 5-7 years of related experience. * Cell Culture experience required. Experience in GMP regulated environment preferred. * Flow Cytometry [FACS CANTO II] experience preferred Physical Requirements: Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards. What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint The anticipated annualized base salary is $85,000 - $105,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Physical Required Job Type Full-time Location Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary) Education Bachelor's Degree Career Level Individual Contributor Travel

About Us We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: The QC Analyst II/III performs advanced quality activities in support of product production and releases with moderate/minimal supervision. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst II/ III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires repetitive hand movement e.g., microtomy, use of biopsy punch, and keyboard use for moderate or long periods of time. This position requires flexibility to work some holidays and occasional 3rd shift as needed to support critical final product release. How You Will Achieve It: * Primary responsibility for the day-to-day activities in the Histology laboratory in support of material and product release testing. * Morphological evaluation for release of final product and/or process development samples * Scientific/technical contributor on cross-functional projects related to Histology activities and assay development/optimization. * Interact and coordinate with Manufacturing and QA Operations daily. * Tracking sample receipt. * Execute assigned tasks with minimal supervision. * Donated tissue receipt and transfer. * Identify and report areas for process improvement. * Generate and execute feasibility/validation protocols. * Generate trend reports as they relate to quality testing. * Work closely with team members to ensure timely release of materials. * Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations. * Assist with inter-departmental interactions to ensure customer service needs are satisfied and priorities understood. * Identifies and implements issues and opportunities for improvements. * Revise/Create SOPs. Job Requirements What You Need to Achieve It: * Minimum requirement; Bachelor's Degree in a Life Science with 3- 4 years of experience in a GMP/GLP regulated environment, ASCP Certified * Utilizes advanced technology and scientific methods in the management of assigned technical specialization * Advanced working knowledge of statistics. Proficient in the use and application of quality tools, databases, and process skills. * Advanced knowledge of relevant Quality System and SOP procedures. Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and regulatory standards. * Advanced knowledge of relevant Quality System and SOP procedures. Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and regulatory standards. * Utilizes advanced technology and scientific methods in the management of assigned technical specialization. * Advanced working knowledge of statistics. Proficient in the use and application of quality tools, databases, and process skills. * Advanced working knowledge of tooling, test equipment, laboratory techniques, and CGMP TEST REQUIREMENTS Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards. What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint The anticipated annualized base salary for a Level II role is $67,200 - $84,000 and for a Level III is $85,000 - $105,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Physical Required Job Type Full-time Location Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary) Education Bachelor's Degree Career Level Individual Contributor Travel

The Inspector I- LFP is an entry level, non-exempt position that reports to the LFP Production Supervisors. The Inspector I is responsible for complying with Charm Sciences, Inc. standard operating procedures, inspecting product, and operating packaging machines. The pay range for this position is $15.50 to $20.00 per hour. Compensation will be determined based on education, experience, and other factors in accordance with applicable laws. Essential Functions Comply with all Charm Sciences, Inc. Standard Operating Procedures (SOP s). Inspect ROSA diagnostic tests as outlined in SOP: FLA-152: Lateral Flow Inspection. Always maintain a clean safe work environment. Load ROSA tests on both manual machine and automatic loaders. Works efficiently on a production line where priorities can shift throughout the day. Report any line issues, product issues or other work-related concerns to the inspector-II, inspector-III or the LFP Production Supervisor. Nothing in this job description restricts management s right to assign or reassign duties and responsibilities to this job at any time. Knowledge, Skills & Abilities Required: Excellent verbal and written communication skills. Work hours for the LFP Department are 7:30 am to 4:00 pm with occasional overtime. This is a temporary position with a tentative end date in late February. Preferred: Basic English vocabulary. 1-2 years experience in a GMP manufacturing environment. Familiarity with Microsoft Windows and Excel. Bilingual: English/Spanish. Physical Requirements The person in this position must be able to frequently lift 10 pounds. Must be able to work continuously in a low humidity environment. The person in this position must be able to remain stationary for an extended length of time while working at a machine. Able to visually inspect lateral flow strips. The person in this position occasionally must operate a computer, a packaging machine and other production equipment. Will be exposed to fluctuating environmental conditions, i.e., temperatures ranging from 4 C in a walk-in cold-room where finished product is stored to 28 C in LFP Dry Rooms.

Milliken & Company is a global manufacturing leader whose focus on materials science delivers tomorrow's breakthroughs today. From industry-leading molecules to sustainable innovations, Milliken creates products that enhance people's lives and deliver solutions for its customers and communities. Drawing on thousands of patents and a portfolio with applications across the textile, flooring, chemical and healthcare businesses, the company harnesses a shared sense of integrity and excellence to positively impact the world for generations. Discover more about Milliken's curious minds and inspired solutions at Milliken.com and on Facebook, Instagram, LinkedIn and Twitter. POSITION TITLE / LOCATION: Quality Control Technician I: 3rd Shift / Salisbury, MA TÍTULO DEL PUESTO / UBICACIÓN: Técnico de Control de Calidad I: 3er turno / Salisbury, MA JOB CLASSIFICATION: Non-Exempt CLASIFICACIÓN DE TRABAJO: No exento POSITION REPORTS TO: Quality Control Supervisor REPORTE DE POSICIÓN A: Supervisor de Control de Calidad POSITION OVERVIEW - RESUME DE LA POSICION Entry level QC technician responsible for conducting standard quality control test methods and process auditing. Técnico de control de calidad de nivel de entrada responsable de realizar métodos de prueba de control de calidad estándar y auditoría de procesos ESSENTIAL JOB DUTIES AND RESPONSIBILITIES DEBERES Y RESPONSABILIDADES LABORALES ESENCIALES * Adhere to all safety policies Cumplir con todas las políticas de seguridad * Understand and follow current good manufacturing practices as defined within Ovik procedures Comprender y seguir las buenas prácticas de fabricación actuales, tal y como se definen en los procedimientos de Ovik * Understand and follow good documentation practices Comprender y seguir las buenas prácticas de documentación * Maintain awareness of ISO 13485 Mantener el conocimiento de la norma ISO 13485 * Understand the manufacturing process from beginning to end Comprender el proceso de fabricación de principio a fin * Understand all QC procedures and be able to perform all QC checks and audits Comprender todos los procedimientos de control de calidad y ser capaz de realizar todas las comprobaciones y auditorías de control de calidad * Update QC test results in SAP Actualizar los resultados de las pruebas de control de calidad en SAP * Prepare and send the QC shift report Preparar y enviar el informe de turno de control de calidad * Prepare test samples and use all QC lab equipment Prepare muestras de prueba y utilice todo el equipo de laboratorio de control de calidad * Correct handling and disposition of nonconforming product Manejo y disposición correctos del producto no conforme * Conduct standard analytical test methods after method and equipment training Llevar a cabo métodos de prueba analíticos estándar después de la capacitación sobre métodos y equipos * Record test data and escalate findings appropriately to supervisor or manager Registre los datos de las pruebas y escale los hallazgos de manera adecuada al supervisor o gerente MINIMUM QUALIFICATIONS - CUALIFICACIONES MÍNIMAS * High school diploma or equivalent PREFERRED QUALIFICATIONS - CALIFICACIONES PREFERIDAS * Laboratory experience Experiencia en laboratorio * Medical device manufacturing experience Experiencia en la fabricación de dispositivos medicos * Bilingual (English/Spanish) Bilingüe (Inglés/Español) SKILL REQUIREMENTS - REQUISITOS DE HABILIDAD * Ability to read, write, and perform basic math at an 8th grade level Capacidad para leer, escribir y realizar matemáticas básicas a un nivel de 8º grado * Competency in Microsoft Outlook, Excel, and Word Competencia en Microsoft Outlook, Excel y Word AUTHORIZED TRAINING TIME - TIEMPO DE FORMACIÓN AUTORIZADO 90 days/90 dias MACHINES, TOOLS AND EQUIPMENT USED: MÁQUINAS, HERRAMIENTAS Y EQUIPOS UTILIZADOS: * Laboratory measuring equipment (scale, viscometer, pH meter, tensile tester, unwind tester, calipers, rulers, beakers, pipettes, etc.) Equipos de medición de laboratorio (báscula, viscosímetro, medidor de pH, probador de tracción, probador de desenrollado, calibradores, reglas, vasos de precipitados, pipetas, etc.) * Sample preparation equipment (knives, die cutters, roll down machine, etc.) Equipo de preparación de muestras (cuchillas, troqueladoras, máquina de enrollar, etc.) PERSONAL PROTECTIVE EQUIPMENT USED: EQUIPOS DE PROTECCIÓN PERSONAL UTILIZADOS: * Safety Eyewear (additional when executing certain tasks) Gafas de seguridad (adicionales al ejecutar ciertas tareas) * Steel Toe Safety Shoes/Zapatos de seguridad con punta de acero * Hairnet/Redecilla * Cut resistant gloves, chemical gloves, etc. as needed/Guantes resistentes a cortes, guantes químicos, etc. según sea necesario * Bump cap/hard hat as needed/Gorra de golpe/casco según sea necesario PHYSICAL REQUIREMENTS FREQUENCY, AMOUNT, OR DESCRIPTION REQUISITOS FÍSICOS FRECUENCIA, CANTIDAD O DESCRIPCIÓN * Standing: Ability to stand while working 80% of day Estar de pie: Capacidad de estar de pie mientras se trabaja * Sitting: Ability to sit down 20% of day Sentado: Capacidad para sentarse * Moving: Ability to move throughout plant: 100% of day Movimiento: Capacidad de moverse a través de la planta: * Lifting: Ability to lift to 25 lbs. 100% of day Elevación: Capacidad de levantar hasta 25 libras * Ascending/Descending: Ability to walk upstairs, climb to top of range (approx. 16 ft) 75% of day Ascendente/Descendente: Capacidad de subir las escaleras, subir a la cima del rango (aprox. 16 pies) * Push/Pull/Reach: Ability to push/pull fabric rolls, A-frames (approx.1500lbs) 10% of day Empujar/Tirar/Alcanzar: Capacidad de empujar/tirar de rollos de tela, marcos en A (aprox. 1500 libras) * Bending: Ability to pick up objects from the floor 25% of day Agacharse: Capacidad de recoger objetos del suelo * Visual Acuity: Visual acuity adequate to perform job duties, including reading information from printed sources and computer screens. 90% of day Agudeza Visual: Agudeza visual adecuada para realizar las tareas laborales, incluyendo la lectura de información de fuentes impresas y pantallas de ordenador. * Cognitive: Alert. Able to make decisions, reason, and understand information. 100% of the day Cognitivo: Alerta. Capaz de tomar decisiones, razonar y comprender información. WORK ENVIRONMENT/SAFETY-SENSITIVE POSITION ENTORNO DE TRABAJO/POSICIÓN SENSIBLE A LA SEGURIDAD This job operates in a manufacturing facility. This position is a safety-sensitive position and regularly works around moving mechanical parts and powered industrial vehicles. Noise level is generally loud. Temperatures can be more than 100 degrees Fahrenheit. Humidity level can be more than 98% for 100% of day. Este trabajo se realiza en una planta de fabricación. Esta posición es sensible a la seguridad y trabaja regularmente alrededor de piezas mecánicas móviles y vehículos industriales motorizados. El nivel de ruido es generalmente alto. Las temperaturas pueden ser de más de 100 grados Fahrenheit. El nivel de humedad puede ser superior al 98% durante el 100% del día. SHIFT/WORK HOURS - TURNOS/HORAS DE TRABAJO Shift schedule will depend on open positions at time of hire and will be communicated with new hire paperwork. Weekends and holidays are scheduled depending on business demands. El horario de turnos dependerá de los puestos vacantes en el momento de la contratación y se comunicará con la documentación de los nuevos contrataciones. Los fines de semana y días festivos se programan en función de las demandas del negocio * To be determined at time of hire A determinar en el momento de la contratación * OT when scheduled OT cuando esté programado Pay Transparency/ Transparencia Salarial: The hourly rate range for this position is $22.00 to $23.00; the exact hourly rate depends on several factors such as experience, skills, education and budget. El rango de salario por hora para este puesto es de $22.00 a $23.00; la tarifa exacta por hora depende de varios factores como la experiencia, las habilidades, la educación y el presupuesto. Milliken is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to actual or perceived race, color, creed, religion, sex or gender (including pregnancy, childbirth or related medical condition, including but not limited to lactation), sexual orientation, gender identity or gender expression (including transgender status), ancestry, national origin, citizenship, age physical or mental disability, genetic information, marital status, veteran or military status or any other characteristic protected by applicable law. It is unlawful in Massachusetts to require or administer a lie dectector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Salary Range:$60,000.00 To $90,000.00 Annually Summary of Responsibilities: The Quality Control Analyst II is primarily responsible for the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions. The position follows established procedures in the execution of daily activities and completes required documentation. Strategic Focus Areas: Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and Quality Control knowledge. Specific Responsibilities: * Testing of incoming raw material according to USP, EP, or ACS Reagent Index * Performance of QC analytical chemistry assays, HPLC, GC & GC/MS, Headspace, Moisture analyzer, Karl Fisher as well as wet chemistry assays. * Testing of in process and release manufacturing samples, stability samples and Engineering/R&D samples using the following instrumentation/techniques: * HPLC * GC & GC/MS * UV/Vis Spectrophotometry * FTIR Spectrophotometry * Auto & Manual Titrations * Freezing Point & Vapor Pressure Osmometry * Absolute Viscosity using Brookfield Cone/Plate Viscometer * Intrinsic Viscosity using Ubbelohde Tube and Dilute Solution Viscometer * pH Meter * TOC Analyzer * Conductivity Meter * Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts * Collaborates with R&D to develop test methods for new products Performance of QC method qualification, validation and transfers * Researches and optimizes Test methods according to accepted industry best practice; performs qualification and validation of methods * Report procedural deviations and nonconformances to management; preforms investigations as assigned and follows through to closure of corrective action * Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required * Performance of QC general laboratory equipment maintenance * Participate in other projects as assigned Job Complexity: The position works on problems of moderate scope in which analysis of situation or data requires review of variable factors. Exercises judgement within defined procedures and practices to determine appropriate action and receives detailed instructions on new projects or assignments. Supervisory Responsibilities: None Required Qualifications: * Requires BS in Chemistry or other Physical Science or equivalent experience. * 2 - 5 years testing experience in FDA regulated pharmaceuticals or medical device industries * Demonstrated experience with GMP/ ISO regulations * Proficient in HPLC, GC analyses and prior experience in method development and method validation. * Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers * Skilled in various wet chemistry techniques such as titrations and compendial ID testing * Constantly strives to exceed goals, requirements, accomplishments and expectations * Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: * Experience with Viscometers, HPLC, GC, GC/MS, TOC Analyzers, or Conductivity Meters * Experience in a results driven, team environment * Ability to handle multiple priorities and meet established deadlines * Experience maintaining spreadsheets and preparing simple graphing is preferred The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

Summary of Responsibilities: The Quality Control Analyst II is primarily responsible for the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions. The position follows established procedures in the execution of daily activities and completes required documentation. Strategic Focus Areas: Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and Quality Control knowledge. Specific Responsibilities: Testing of incoming raw material according to USP, EP, or ACS Reagent Index Performance of QC analytical chemistry assays, HPLC, GC & GC/MS, Headspace, Moisture analyzer, Karl Fisher as well as wet chemistry assays. Testing of in process and release manufacturing samples, stability samples and Engineering/R&D samples using the following instrumentation/techniques: HPLC GC & GC/MS UV/Vis Spectrophotometry FTIR Spectrophotometry Auto & Manual Titrations Freezing Point & Vapor Pressure Osmometry Absolute Viscosity using Brookfield Cone/Plate Viscometer Intrinsic Viscosity using Ubbelohde Tube and Dilute Solution Viscometer pH Meter TOC Analyzer Conductivity Meter Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts Collaborates with R&D to develop test methods for new products Performance of QC method qualification, validation and transfers Researches and optimizes Test methods according to accepted industry best practice; performs qualification and validation of methods Report procedural deviations and nonconformances to management; preforms investigations as assigned and follows through to closure of corrective action Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Performance of QC general laboratory equipment maintenance Participate in other projects as assigned Job Complexity: The position works on problems of moderate scope in which analysis of situation or data requires review of variable factors. Exercises judgement within defined procedures and practices to determine appropriate action and receives detailed instructions on new projects or assignments. Supervisory Responsibilities: None Required Qualifications: Requires BS in Chemistry or other Physical Science or equivalent experience. 2 - 5 years testing experience in FDA regulated pharmaceuticals or medical device industries Demonstrated experience with GMP/ ISO regulations Proficient in HPLC, GC analyses and prior experience in method development and method validation. Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers Skilled in various wet chemistry techniques such as titrations and compendial ID testing Constantly strives to exceed goals, requirements, accomplishments and expectations Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: Experience with Viscometers, HPLC, GC, GC/MS, TOC Analyzers, or Conductivity Meters Experience in a results driven, team environment Ability to handle multiple priorities and meet established deadlines Experience maintaining spreadsheets and preparing simple graphing is preferred The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

PURPOSE: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst is technically independent and has mastered fundamental quality control concepts as well as some specialized technologies. Independently coordinates activities with others both inside QC and outside the department and carries out projects with minimal supervision. Displays initiative and technical commitment and independence for study design. Organizes and provides written and/or oral presentations of work with minimal input from Supervisor. Displays ability to perform more complex studies and to make independent contributions to the development of new technologies. Provides guidance and training to other staff members. GENERAL RESPONSIBILITIES: Technical Expertise Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures Test methods may include (but are not limited to): Environmental Monitoring Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems Perform Growth Promotion testing of microbiological media Perform Plate reading, streaking, gram staining, and microbial ID Perform Sterility Testing Product Release and Stability Testing Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's Perform complex testing in accordance with written protocols Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic) Performs Karl Fisher titration for moisture Performs pH determination Performs container closure testing Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin Prepares and reviews Certificates of Analysis Formulates and tests feasibilities for final product ratios Raw Materials Receiving Inspection of Raw Materials Testing of Raw materials Data Analysis Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete. General Lab Support Test sample management and handling, maintenance of lab equipment and logbooks, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories Participate in safety, customer, and quality audits including answering questions during tours Maintain and review logbooks related to equipment and inventory, may assist in ordering materials, reagents and supplies May be responsible for coordination of intra and/or interdepartmental activities Participate in safety, customer, and quality audits including answering questions during tours and providing written responses to audit findings as assigned Preparation of glassware for Laboratory use. Managing/Handling Hazardous Waste Problem Solving/ Decision Making Technically independent and contributes substantially to the interpretation of results and design of follow up studies. Propose next steps to Supervisor for approval prior to execution. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals Independently communicates interdepartmentally and with outside contacts to solve technical issues and communicates results to the Supervisor. Propose to Supervisor investigative and troubleshooting of Quality Control Methods and SOP's to improve compliance, efficiency and/or reduce cost (e.g. recommend purchase of new equipment or instrument to upgrade or replace obsolete model, identify new alternative methodology/technologies, performing gap analysis to ensure alignment with cGMP or regulatory guidance's) . Present idea to Supervisor for approval Utilize colleagues and literature to solve complex problems Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed Represent QC at cross functional meetings as assigned in a leadership capacity (this includes disseminating information in a professional manner with the groups goals represented) Planning Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing) Prepare reports independently and submit them to the Supervisor for approval. Reports should be ready for upper management review at time of submission to Supervisor Prepare metrics reports including statistical analysis of results when required Prepare training plans when required Supervision Receives overall direction from Supervisor and carries out test without supervision. May supervise junior staff members Provides training of other staff members Perform other additional job-related duties as required Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs. KNOWLEDGE AND SKILL REQUIREMENTS: Organizational skills Time management skills General laboratory skills Must be detailed oriented and show proficiency in aseptic and laboratory technique Ability to work independently, as well as participate in teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control Required to pass a pipetting proficiency training and certification course Required to pass LAL Training and Certification EDUCATION AND EXPERIENCE: A minimum of a B.S. degree in a relevant scientific discipline or equivalent or a combination of experience and education required w/ 4-6+ years of laboratory experience within a cGMP regulated environment. M.S. degree in a relevant scientific discipline preferred w/ 4+ years of laboratory experience within a cGMP regulated environment. GENERAL JOB COMPETENCIES: Create and edit documents utilizing Word, Excel, PowerPoint and LIMS. Meet deadlines, work independently, accountable, maintain focus, punctual, good attendance record Information is organized and accessible, maintains efficient workspace, manages time well. Manage workload, work efficiently, and meet goals and objectives Strive to eliminate errors, accurate work is a priority, compliant with quality system requirements. Maintain current understanding of technical processes/equipment. PHYSICAL REQUIREMENTS: Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand). The ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gowns, and facemasks is required. SALARY: $49,000-$65,000 a year BENEFITS: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Professional development assistance Referral program Tuition reimbursement Vision insurance

The Equipment QC Analyst I is an entry level, non-exempt position that reports to EQC Management. The Equipment QC Analyst is responsible for calibrating diagnostic equipment and ensuring it meets the quality standards set by Charm Sciences Inc. The pay range for this position is $22.00 to $31.00 per hour. Compensation will be determined based on education, experience, and other factors in accordance with applicable laws. Essential Functions Calibrate equipment manufactured by Charm Sciences, Inc and ensure that it meets the quality standards set by the company Completion of customer equipment orders Record, document, and summarize calibration and testing data for review by EQC Manager Follow and update standard operating procedures Nothing in this job description restricts management s right to assign or reassign duties and responsibilities to this job at any time Knowledge, Skills & Abilities Required: BS in Biochemistry or related life science s field Familiarity with Microsoft Excel, Word, and Outlook Understanding of basic statistics Excellent attention to detail Must be available 8:30am to 5:30pm Monday through Friday Preferred: 1-3 years QC experience 1-3 years GMP/GLP experience Understanding of aseptic/sterile technique Advanced knowledge of MS Excel Strong verbal and written communication skills Ability to give and receive feedback Self-Motivated Good communication & interpersonal skills Diligent and dependable Strong organizational skills Physical Requirements Able to lift up to 25 pounds periodically Occasionally move bins weighing up to 25 pounds across the facility Able to remain in a stationary position for an extended length of time Constantly operates handheld diagnostic devices, a computer, and other office equipment such as a printer Able to work 10 to 15 minutes in a cold room environment (4 C) Able to operate micro-pipettors repeatedly and accurately