What are the responsibilities and job description for the Lead Quality Auditor position at MESO SCALE DIAGNOSTICS, LLC.?
POSITION SUMMARY
The Lead Quality Auditor is responsible for the execution and documentation of the Quality Audits system / processes for the auditing of internal processes for MSD. These audits are conducted to ensure the on-going compliance of MSD’s Quality System to the company’s active regulatory certifications, e.g. ISO 9001, ISO 13485, FDA regulations (as applicable). Responsibilities will include providing support for implementation of corporate quality system improvements and mentoring of MSD internal auditors.
DUTIES AND RESPONSIBILITIES
- Maintain and execute the Internal Audits audit program as per the published schedule with complete audits, timely reports, audit communications and audit follow-up and follow-through. This will include but is not limited to :
- Draft audit reports
- Follow up and close audits
- Monitor CAPA activities
- Assist in answering questions and concerns generated from audits
- Schedule follow up for corrective action responses
- Ensure appropriate problem resolution methods are utilized and that verification of effectiveness has been completed.
- Review customer questionnaires and provide QA input as required under guidance of supervisor.
- Maintain the Approved Supplier List (ASL) and documented evidence of evaluation records.
- Maintain on-going communication both inter and intra-departmental for status of projects, activities and audits.
- Mentor and provide guidance to MSD staff participating in internal audits.
- Other duties as assigned.
EXPERIENCE AND QUALIFICATIONS
KNOWLEDGE, SKILLS AND ABILITIES
PHYSICAL DEMANDS
WORK ENVIRONMENT
COMPENSATION SUMMARY
The annual base salary for this position ranges from $76,100 to $113,200. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.
BENEFITS SUMMARY
At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.
EEO / AA STATEMENT
MSD is an Equal Opportunity / Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO / AA and Pay Transparency statement, please visit here . Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Salary : $76,100 - $113,200
