Job Title

Quality Analyst

Requisition

JR000014219 Quality Analyst (Open)

Location

CC-Madison - USA503

Additional Locations

Madison, WI

Job Description

The Quality Analyst ensures that all materials, activities, processes, and specified conditions involved in daily device manufacturing, processing, and packaging meet current GMP standards and comply with relevant procedures and standards to maintain product quality integrity. Additionally, the Quality Analyst manages nonconforming material reports, plans material review board meetings, and oversees the status of quarantined and scrapped materials.

Essential Functions

• Collaborating regularly with representatives from Quality, Purchasing, Engineering, and Manufacturing to resolve nonconforming material reports.

• Tracking and trending nonconforming material reports to ensure quality processes remain controlled.

• Analyzing failure modes and performing statistical analysis of nonconforming parts.

• Reviewing nonconforming material reports, addressing discrepancies, and escalating issues to management as necessary.

• Preparing for material review board meetings and acting as a backup Quality representative during these meetings.

• Ensuring all nonconforming parts are properly controlled using the on-site quarantine cage.

• Updating the status of all nonconforming parts appropriately within SAP.

• Developing, implementing, and maintaining QA procedures, standards, and controls.

• Supporting Quality through occasional investigations of nonconformance and assisting with corrective and preventive actions associated with the QA unit.

• Performing internal and external audits of systems and suppliers.

• Assisting with site audit support.

• Managing documentation as required.

• Supporting other Quality System functions.

• Assisting with the completion of supplier corrective action reports.

Minimum Requirements

• Associates degree with 3+ years experience managing complaints and investigations with metrics in pharma/medical device industry - OR - Bachelor’s Degree with 1+ years

• Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing

• High level of motivation; ability to work independently.

• Ability to communicate well, both verbally and written

• Collaborative with strong levels of engagement with individuals and as a team member

• Participation experience with internal, external and supplier audits

Preferences:

• 3+ years working in medical device industry

• Strong Statistical background

• Auditor Certification (ASQ CQA or CMDA)

Organizational Relationship/Scope:

Reports to the Quality Control Manager. This position is accountable for delivery of the highest quality products according to defined forecast and schedule. Working across multiple functions, this position collaborates primarily with manufacturing and quality to resolve product production related issues.

Working Conditions:

Manufacturing facility of medical devices and accessories. Controlled environmental working conditions. This will be a fully onsite (100%) role.

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.