Lead Quality Auditor

MESO SCALE DIAGNOSTICS, LLC.; Rockville (MD); On-site; USD 76,000 - 114,000; Full time

Job summary

An established industry player is seeking a Lead Quality Auditor to ensure compliance with quality systems and regulatory standards. This role involves executing internal audits, mentoring internal auditors, and supporting the implementation of quality system improvements. The ideal candidate will possess a strong background in ISO auditing and quality assurance, with excellent analytical and communication skills. Join a dynamic team dedicated to maintaining high standards and improving processes in a supportive environment where your contributions will have a significant impact.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) with company matching

Short- and long-term disability insurance

Paid vacation

Paid sick leave

Employee assistance program

Fitness club membership contribution

Pet insurance

Qualifications

• 5+ years of ISO or QSR auditing experience required.
• Strong analytical background and problem-solving skills.
• Experience mentoring in quality systems topics.

Responsibilities

• Execute and document internal quality audits for compliance.
• Mentor staff participating in internal audits.
• Maintain communication regarding audit statuses.

Skills

ISO Auditing

Quality System Compliance

Analytical Skills

Communication Skills

Problem Solving

Education

Bachelor’s degree in sciences or engineering

ASQ Certification (CQA, CQE)

Tools

MS Office Suite

Visio

ERP Software

Project Management Tools

Job description

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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:
• 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

• Bachelor’s degree in the sciences, engineering or health related field required. Bachelor’s degree in other fields with additional years of relevant industry and work experience will be considered.
• Minimum of 5 years of ISO or QSR auditing experience is required. 3 years’ experience as a lead auditor in an ISO or QSR environment is strongly preferred.
• Experience working with FDA and/or ISO auditors preferred
• Current ASQ certification (CQA, CQE) is strongly preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Strong audit fundamentals and analytical background
• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
• Excellent oral, written communication and interpersonal skills
• Demonstrated ability to mentor in quality systems topics including ISO, QSR and auditing
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of audit data
• Proficiency in MS Office Suite
• Experience with standard data analysis tools (Visio, ERP and Project Management) and the quantitative background to advance this knowledge on the job is expected
• Ability to multi-task and work productively in a demanding production environment with changing priorities

PHYSICAL DEMANDS

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
• Walk through MSD and supplier facilities as part of on-site audits and inspections.

WORK ENVIRONMENT

• Standard office environment
• Up to 30% travel required

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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