SUMMARY DESCRIPTIONThe Quality Assurance group is dedicated to ensuring product compliance in support of site Manufacturing and Operations. This includes managing critical Quality System elements such as CAPA, Control of Nonconforming Product, Change Control, and Quality Control, Validation, and Compliance. The team collaborates closely with Operations and Manufacturing Engineering groups to maintain high product quality, maintain compliance, and implement effective and efficient corrective and preventive actions as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIESSubject Matter Expert and leader for key Quality areas including Process Validation, Change Control, Control of Nonconforming Product, & CAPA (Corrective & Preventative Actions), and Document Control.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Assist or lead in the identification, investigation, root cause analysis, implementation, and effectiveness verification of CAPA.
- Assist or lead Control of Nonconforming Product process activities (e.g., disposition review/approval and containment action activities).
- Evaluate impact assessments and risk assessments related to CAPA and NCMR.
- Provide QA on-the-floor support to Operations, Manufacturing Engineering, and QC as needed.
- Support new product development and production (e.g., Change Control review and approval for New Product Introduction).
- Support validations for new and existing products, processes, and equipment (document/change order reviews and approvals).
- Assist in measurement methods, MSA, TMVs, and GRR.
- Lead Quality Representative on projects & meetings
- Establish and maintain Quality Management System procedures related to areas of responsibility.
- Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/standards.
- Lead audits for the Internal Audit program.
- Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.
- Identify and implement opportunities for continuous improvement.
- Collect and report metrics and data as required.
- Perform other Quality Management System related duties as required.
Note: Other duties may be assigned as necessary.
DESIRED MINIMUM QUALIFICATIONSThe following qualifications represent the knowledge, skills, and abilities required for this position:
Education & Experience:
- BS degree in Engineering, Math, or Science (Biology, Chemistry, Physics, Statistics, etc.) with 5+ years of working experience in Quality Assurance/Control.
- Minimum of 5 years' experience in a regulated industry, preferably the Medical Device Industry.
- Working knowledge of critical Quality System elements related to QA Engineering, including CAPA, Control of Nonconforming Product, Change Control, Validation, and Quality Control. In addition, provide a high level of QA on the floor support to Operations, Manufacturing Engineering, and Quality Control.
- Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
- Experience with measurement systems and statistical techniques to support Quality Control.
- Experience leading CAPA investigations.
- Working knowledge of medical device regulations (including FDA QSRs, ISO13485).
- Experience in high precision machining processes is highly desired.
- Ability to communicate effectively skills (both written and oral) in English (or local language).
- Strong technical writing skills.
- Proficiency with the MS Office Suite, including Microsoft Visio and Project.
- Ability to consistently observe company policies and safety procedures.
- Demonstrated ability to work cross-functionally in a team environment.
- Ability to work independently with minimal supervision.
- Must treat others with respect, work with integrity and ethically, and uphold organizational values.
TOOLS AND EQUIPMENT USEDAbility to utilize a computer, telephone, fax and copy machine as well as other general office equipment.
PHYSICAL REQUIREMENTSWhile undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type, and move throughout the facility. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
The physical requirements listed in this section include, but are not limited to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
ADVERSE WORKING CONDITIONSWhile performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, high precarious places, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.
Salary Pay Range:
$95,000.00 - $130,000.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
