Website Artech LLC
Artech LLC
Company : Artech LLC
JOB TITLE: SR Quality Engineer
JOB ID: 20138
LOCATION: 620 Watson Street SW Grand Rapids Michigan 49504
DURATION: 12 MONTHS
Payrate: $60-70/HR
Top 3 technical skills that are required for the role:
1. Root Cause Analysis (RCA): Skills in identifying and resolving issues using tools like 5 Whys, Ishikawa diagrams and corrective/preventive actions (CAPA).
2. Risk Management: Strong understanding of risk analysis tools like FMEA (Failure Modes and Effects Analysis) and fault tree analysis to mitigate product and process risks.
3. Quality Management Systems (QMS): Expertise in managing and implementing QMS, including ISO 13485 and FDA regulations specific to medical devices.
Years Experience Required:
Education & Experience:
Master s degree in Industrial Engineering or a related engineering field with at least three (3) years of experience as a Quality Engineer or in a related role; OR Bachelor s degree in Industrial Engineering or a related engineering field with at least five (5) years of experience as a Quality Engineer or in a related role. Required Technical Expertise (Minimum 3 years of experience in each of the following areas):
Regulatory Standards & Compliance:
ISO 13485 (Quality Management Systems for Medical Devices)
ISO 14971 (Application of Risk Management to Medical Devices)
21 CFR Part 820 (Quality System Regulation for Medical Devices)
21 CFR Part 11 (Electronic Records and Signatures)
Good Manufacturing Practices (GMP)
Risk Management & Validation:
Risk Management methodologies, including risk assessment and mitigation strategies.
Test Method Validation (TMV)
Design Validation and Verification processes
Process Validation (IQ/OQ/PQ)
Documentation & Records Management:
Proficient in creating, maintaining, and managing essential documentation, including Design History Files (DHF) and Device Master Records (DMR), in compliance with regulatory requirements.
Excellent Technical Writing Skills:
Ability to produce clear, concise, and detailed documentation for validation reports, risk management files, work instructions, and regulatory submissions.
Nonconformance & Product Investigations:
Skilled in managing and resolving Non-Conformance Material Reports (NCMRs) to ensure timely and effective disposition of nonconforming materials.
Experienced in conducting thorough product investigations and failure analysis to identify root causes and recommend corrective actions.
Proficient in product investigation and containment by implementing and enhancing in-place processes to mitigate risks and maintain product quality.
Extensive experience in performing Root Cause Analysis (RCA) to uncover underlying issues and drive the implementation of Corrective and Preventive Actions (CAPA) for sustained improvements.
Additional Competencies:
Strong analytical and problem-solving skills with a focus on continuous improvement.
Excellent communication and technical writing skills for clear and concise documentation.
Proficiency in quality tools such as Six Sigma, Lean Manufacturing principles, and statistical analysis software (e.g., Minitab).
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, this person will work at least 40 hours a week.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? The candidate must be 100% of the time onsite.
What is your timeline for scheduling interviews? The plan is to start interviewing candidates as soon as possible, making any adjustments needed on my calendar.
What product line will this person support? This candidate will support Cardiovascular Products such as Arterial Cannulae and Revascularization Products.
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.